Trial Outcomes & Findings for An Exploratory Study of Telaprevir in Treatment-Naive Participants With Chronic Genotype 4 Hepatitis C Virus Infection (NCT NCT00580801)
NCT ID: NCT00580801
Last Updated: 2013-09-09
Results Overview
The plasma HCV RNA levels were used to assess the antiviral activity which included viral response as either undetectable HCV RNA (that is no HCV target was detected in the plasma sample) or less than 25 International unit per milliliter (IU/mL) of HCV RNA (that is Plasma sample contained HCV RNA at a concentration below the limit of quantification \[LLOQ=25 IU/mL\] of the viral load assay). Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test Version 2.0. This assay used real-time reverse transcription-polymerase chain reaction (RT-PCR) methodology.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Baseline and Day 15
Results posted on
2013-09-09
Participant Flow
Participant milestones
| Measure |
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin
Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection \[injected under the skin by way of a needle\], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
|
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin
Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
Placebo+Pegylated-interferon-alfa-2a+Ribavirin
Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
2
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
3
|
Reasons for withdrawal
| Measure |
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin
Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection \[injected under the skin by way of a needle\], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
|
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin
Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
Placebo+Pegylated-interferon-alfa-2a+Ribavirin
Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
2
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
|
Overall Study
Reached a virologic endpoint
|
0
|
1
|
2
|
|
Overall Study
Participant non-compliant
|
0
|
0
|
1
|
|
Overall Study
Travel
|
1
|
0
|
0
|
Baseline Characteristics
An Exploratory Study of Telaprevir in Treatment-Naive Participants With Chronic Genotype 4 Hepatitis C Virus Infection
Baseline characteristics by cohort
| Measure |
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin
n=8 Participants
Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection \[injected under the skin by way of a needle\], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
|
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin
n=8 Participants
Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
Placebo+Pegylated-interferon-alfa-2a+Ribavirin
n=8 Participants
Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age Continuous
|
43 Years
n=5 Participants
|
41 Years
n=7 Participants
|
46 Years
n=5 Participants
|
45.5 Years
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Region of Enrollment
France
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 15Population: Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo. "n" signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
The plasma HCV RNA levels were used to assess the antiviral activity which included viral response as either undetectable HCV RNA (that is no HCV target was detected in the plasma sample) or less than 25 International unit per milliliter (IU/mL) of HCV RNA (that is Plasma sample contained HCV RNA at a concentration below the limit of quantification \[LLOQ=25 IU/mL\] of the viral load assay). Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test Version 2.0. This assay used real-time reverse transcription-polymerase chain reaction (RT-PCR) methodology.
Outcome measures
| Measure |
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin
n=8 Participants
Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection \[injected under the skin by way of a needle\], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
|
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin
n=8 Participants
Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
Placebo+Pegylated-interferon-alfa-2a+Ribavirin
n=8 Participants
Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
|---|---|---|---|
|
Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15
HCV RNA levels: Baseline (n=8,8,8)
|
5.83 log 10 IU/mL
Interval 5.2 to 6.5
|
6.16 log 10 IU/mL
Interval 5.4 to 6.8
|
5.88 log 10 IU/mL
Interval 5.0 to 6.8
|
|
Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15
HCV RNA levels: Change at Day 15 (n=7,8,8)
|
-0.77 log 10 IU/mL
Interval -2.9 to 0.3
|
-4.32 log 10 IU/mL
Interval -5.2 to 0.0
|
-1.58 log 10 IU/mL
Interval -4.0 to -0.8
|
SECONDARY outcome
Timeframe: Day 15 up to EOT (Week 48/50 or early discontinuation)Population: Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo. "n" signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
Viral response was either defined as having undetectable HCV RNA (that is, no HCV RNA was detected in the participants' plasma samples) or less than 25 IU/mL HCV RNA from Day 15 up to end of treatment (EOT), that is Week 48/50 or early discontinuation. In Week x/y, where, x represents time frame for Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin and Placebo+Pegylated-interferon-alfa-2a+Ribavirin and; y represents time frame for Telaprevir and Pegylated-interferon-alfa-2a+Ribavirin treatment group.
Outcome measures
| Measure |
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin
n=8 Participants
Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection \[injected under the skin by way of a needle\], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
|
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin
n=8 Participants
Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
Placebo+Pegylated-interferon-alfa-2a+Ribavirin
n=8 Participants
Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
|---|---|---|---|
|
Percentage of Participants With Viral Response (Undetectable HCV RNA)
Day 15 (n=7, 8, 8)
|
0 Percentage of participants
|
12.5 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Viral Response (Undetectable HCV RNA)
Week 4/6 (n=7, 8, 8)
|
42.9 Percentage of participants
|
37.5 Percentage of participants
|
12.5 Percentage of participants
|
|
Percentage of Participants With Viral Response (Undetectable HCV RNA)
Week 12/14 (n=7, 8, 7)
|
85.7 Percentage of participants
|
75.0 Percentage of participants
|
57.1 Percentage of participants
|
|
Percentage of Participants With Viral Response (Undetectable HCV RNA)
Week 24/26 (n=6, 8, 8)
|
100 Percentage of participants
|
87.5 Percentage of participants
|
62.5 Percentage of participants
|
|
Percentage of Participants With Viral Response (Undetectable HCV RNA)
Week 36/38 (n=6, 8, 5)
|
100 Percentage of participants
|
75.0 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants With Viral Response (Undetectable HCV RNA)
Week 48/50 (n=4, 7, 5)
|
100 Percentage of participants
|
85.7 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants With Viral Response (Undetectable HCV RNA)
EOT (n=8, 8, 8)
|
87.5 Percentage of participants
|
75.0 Percentage of participants
|
75.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 48/50Population: Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo.
Time to first viral response (Undetectable HCV RNA) is defined as the number of days since the start of study medication until first time negative HCV RNA level that is less than 25 IU/mL was detected.
Outcome measures
| Measure |
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin
n=8 Participants
Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection \[injected under the skin by way of a needle\], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
|
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin
n=8 Participants
Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
Placebo+Pegylated-interferon-alfa-2a+Ribavirin
n=8 Participants
Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
|---|---|---|---|
|
Median Time to First Viral Response (Undetectable HCV RNA)
|
93 Days
Interval 44.0 to 100.0
|
85.50 Days
Interval 29.0 to 171.0
|
128 Days
Interval 86.0 to 200.0
|
SECONDARY outcome
Timeframe: Day 8, Day 12, Day 15, Week 24/26 and Week 36/38Population: Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo.
Viral breakthrough was defined as having a confirmed increase greater than 1 log 10 in HCV RNA level from the lowest level reached, or a confirmed level of HCV RNA greater than 100 IU/mL in participants whose HCV RNA had previously become undetectable \[less than 25 IU/mL\]). In Week x/y, where, x represents time frame for Telaprevir+pegylated-interferon-alfa-2a+Ribavirin and Placebo+pegylated-interferon-alfa-2a+Ribavirin and y represents time frame for Telaprevir and then Pegylated-interferon-alfa-2a+Ribavirin treatment group.
Outcome measures
| Measure |
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin
n=8 Participants
Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection \[injected under the skin by way of a needle\], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
|
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin
n=8 Participants
Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
Placebo+Pegylated-interferon-alfa-2a+Ribavirin
n=8 Participants
Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
|---|---|---|---|
|
Number of Participants With Viral Breakthrough (Detectable HCV RNA)
Day 8
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Viral Breakthrough (Detectable HCV RNA)
Day 12
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Viral Breakthrough (Detectable HCV RNA)
Day 15
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Viral Breakthrough (Detectable HCV RNA)
Week 24/26
|
5 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Viral Breakthrough (Detectable HCV RNA)
Week 36/38
|
5 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 12 and 24 after the last dose of study medicationPopulation: Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo.
Sustained viral response was defined as having undetectable HCV RNA at EOT (Week 48/50 or early discontinuation) and no confirmed detectable HCV RNA levels between EOT and 12 weeks (SVR12) and 24 weeks (SVR24) after the last dose of study medication.
Outcome measures
| Measure |
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin
n=8 Participants
Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection \[injected under the skin by way of a needle\], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
|
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin
n=8 Participants
Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
Placebo+Pegylated-interferon-alfa-2a+Ribavirin
n=8 Participants
Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
|---|---|---|---|
|
Percentage of Participants With Sustained Viral Response (SVR)
SVR12
|
75.0 Percentage of participants
|
50.0 Percentage of participants
|
62.5 Percentage of participants
|
|
Percentage of Participants With Sustained Viral Response (SVR)
SVR24
|
62.5 Percentage of participants
|
50.0 Percentage of participants
|
62.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 24 after EOT (Week 48/50 or early discontinuation)Population: Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo. "N" signifies those participants who were evaluated for this measure.
Relapse was defined as having confirmed detectable HCV RNA during the 24-week follow-up period in participants who had undetectable HCV RNA at EOT (Week 48/50 or early discontinuation). Participants who dropped out between 24-week follow-up after EOT were not evaluated for relapse.
Outcome measures
| Measure |
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin
n=7 Participants
Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection \[injected under the skin by way of a needle\], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
|
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin
n=6 Participants
Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
Placebo+Pegylated-interferon-alfa-2a+Ribavirin
n=6 Participants
Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
|---|---|---|---|
|
Percentage of Participants With Relapse
|
14.3 Percentage of participants
|
33.3 Percentage of participants
|
16.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15Population: Intent-to-treat (ITT) population included any randomized participant who received at least 1 dose of telaprevir/placebo. "n" signifies number of participants with data for this measure at the specified time point for each arm group respectively.
The AUC is a measure of the serum concentration-time curve, calculated by the lin-up/log-down method.
Outcome measures
| Measure |
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin
n=8 Participants
Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection \[injected under the skin by way of a needle\], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
|
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin
n=8 Participants
Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
Placebo+Pegylated-interferon-alfa-2a+Ribavirin
Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
|---|---|---|---|
|
Area Under the Serum Concentration-Time Curve (AUC)
AUC : Day 1 (n=8, 7)
|
6702 nanogram*hour/milliliter (ng*h/mL)
Standard Deviation 3284
|
7467 nanogram*hour/milliliter (ng*h/mL)
Standard Deviation 4684
|
—
|
|
Area Under the Serum Concentration-Time Curve (AUC)
AUC : Day 15 (n=7, 7)
|
17120 nanogram*hour/milliliter (ng*h/mL)
Standard Deviation 3599
|
23320 nanogram*hour/milliliter (ng*h/mL)
Standard Deviation 7065
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15Population: ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. "n" signifies number of participants with data for this measure at the specified time point for each arm group respectively.
The Cmax is the maximum observed serum concentration, which was measured at Day 1 and 15 for telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test).
Outcome measures
| Measure |
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin
n=8 Participants
Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection \[injected under the skin by way of a needle\], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
|
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin
n=8 Participants
Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
Placebo+Pegylated-interferon-alfa-2a+Ribavirin
Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of Telaprevir
Cmax: Day 1 (n=8, 8)
|
1598 Nanogram/milliliter (ng/mL)
Standard Deviation 803.1
|
1709 Nanogram/milliliter (ng/mL)
Standard Deviation 1017
|
—
|
|
Maximum Serum Concentration (Cmax) of Telaprevir
Cmax: Day 15 (n=7, 7)
|
2733 Nanogram/milliliter (ng/mL)
Standard Deviation 554.9
|
3669 Nanogram/milliliter (ng/mL)
Standard Deviation 1017
|
—
|
SECONDARY outcome
Timeframe: 0 hour (pre-dose) at Day 15Population: ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. "N" signifies those participants who were evaluated for this measure.
The C(0h) is the pre-dose serum concentration of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test).
Outcome measures
| Measure |
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin
n=6 Participants
Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection \[injected under the skin by way of a needle\], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
|
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin
n=5 Participants
Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
Placebo+Pegylated-interferon-alfa-2a+Ribavirin
Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
|---|---|---|---|
|
Pre-Dose Serum Concentration (C[0h]) of Telaprevir
|
1873 Nanogram/milliliter (ng/mL)
Standard Deviation 376.6
|
2806 Nanogram/milliliter (ng/mL)
Standard Deviation 1056.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 15Population: ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. "N" signifies those participants who were evaluated for this measure.
The Cmin is the minimum serum concentration between 0 hour and τ (τ=dosing interval) of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test). Cmin on Day 15 is reported here.
Outcome measures
| Measure |
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin
n=7 Participants
Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection \[injected under the skin by way of a needle\], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
|
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin
n=7 Participants
Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
Placebo+Pegylated-interferon-alfa-2a+Ribavirin
Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
|---|---|---|---|
|
Minimum Serum Concentration (Cmin) of Telaprevir on Day 15
|
1639 Nanogram/milliliter (ng/mL)
Standard Deviation 447.7
|
2100 Nanogram/milliliter (ng/mL)
Standard Deviation 796.3
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15Population: ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. "n" signifies number of participants with data for this measure at the specified time point for each arm group respectively.
The tmax is the time to reach maximum observed serum concentration of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and pegylated-interferon-alfa-2a+Ribavirin (test).
Outcome measures
| Measure |
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin
n=8 Participants
Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection \[injected under the skin by way of a needle\], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
|
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin
n=8 Participants
Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
Placebo+Pegylated-interferon-alfa-2a+Ribavirin
Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
|---|---|---|---|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Telaprevir
tmax: Day 1 (n=8, 8)
|
4.02 Hours
Full Range 447.7 • Interval 3.0 to 5.97
|
4.00 Hours
Full Range 796.3 • Interval 3.0 to 6.0
|
—
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Telaprevir
tmax: Day 15 (n=7, 7)
|
2.92 Hours
Interval 0.0 to 4.08
|
3.00 Hours
Interval 1.92 to 4.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15Population: ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. "N" signifies those participants who were evaluated for this measure.
The Average steady-state serum concentration (Css,av) was calculated by AUC/τ at steady-state (τ=dosing interval) of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test).
Outcome measures
| Measure |
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin
n=7 Participants
Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection \[injected under the skin by way of a needle\], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
|
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin
n=7 Participants
Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
Placebo+Pegylated-interferon-alfa-2a+Ribavirin
Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
|---|---|---|---|
|
Average Steady-State Serum Concentration (Css,av) of Telaprevir
|
2141 Nanogram/milliliter (ng/mL)
Standard Deviation 438.5
|
2896 Nanogram/milliliter (ng/mL)
Standard Deviation 842.0
|
—
|
Adverse Events
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo+Pegylated-interferon-alfa-2a+Ribavirin
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin
n=8 participants at risk
Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection \[injected under the skin by way of a needle\], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
|
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin
n=8 participants at risk
Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
Placebo+Pegylated-interferon-alfa-2a+Ribavirin
n=8 participants at risk
Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
|---|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
12.5%
1/8 • 2 weeks
|
0.00%
0/8 • 2 weeks
|
0.00%
0/8 • 2 weeks
|
Other adverse events
| Measure |
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin
n=8 participants at risk
Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection \[injected under the skin by way of a needle\], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
|
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin
n=8 participants at risk
Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
Placebo+Pegylated-interferon-alfa-2a+Ribavirin
n=8 participants at risk
Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8 • 2 weeks
|
12.5%
1/8 • 2 weeks
|
0.00%
0/8 • 2 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
25.0%
2/8 • 2 weeks
|
25.0%
2/8 • 2 weeks
|
0.00%
0/8 • 2 weeks
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • 2 weeks
|
25.0%
2/8 • 2 weeks
|
0.00%
0/8 • 2 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
1/8 • 2 weeks
|
12.5%
1/8 • 2 weeks
|
0.00%
0/8 • 2 weeks
|
|
Gastrointestinal disorders
Anal pruritus
|
12.5%
1/8 • 2 weeks
|
12.5%
1/8 • 2 weeks
|
0.00%
0/8 • 2 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • 2 weeks
|
12.5%
1/8 • 2 weeks
|
0.00%
0/8 • 2 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • 2 weeks
|
12.5%
1/8 • 2 weeks
|
0.00%
0/8 • 2 weeks
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/8 • 2 weeks
|
12.5%
1/8 • 2 weeks
|
0.00%
0/8 • 2 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • 2 weeks
|
12.5%
1/8 • 2 weeks
|
0.00%
0/8 • 2 weeks
|
|
General disorders
Fatigue
|
37.5%
3/8 • 2 weeks
|
12.5%
1/8 • 2 weeks
|
0.00%
0/8 • 2 weeks
|
|
General disorders
Influenza like illness
|
37.5%
3/8 • 2 weeks
|
87.5%
7/8 • 2 weeks
|
50.0%
4/8 • 2 weeks
|
|
General disorders
Asthenia
|
0.00%
0/8 • 2 weeks
|
75.0%
6/8 • 2 weeks
|
37.5%
3/8 • 2 weeks
|
|
General disorders
Malaise
|
0.00%
0/8 • 2 weeks
|
0.00%
0/8 • 2 weeks
|
12.5%
1/8 • 2 weeks
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • 2 weeks
|
12.5%
1/8 • 2 weeks
|
12.5%
1/8 • 2 weeks
|
|
Nervous system disorders
Lethargy
|
12.5%
1/8 • 2 weeks
|
0.00%
0/8 • 2 weeks
|
0.00%
0/8 • 2 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
12.5%
1/8 • 2 weeks
|
25.0%
2/8 • 2 weeks
|
0.00%
0/8 • 2 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/8 • 2 weeks
|
12.5%
1/8 • 2 weeks
|
12.5%
1/8 • 2 weeks
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
0.00%
0/8 • 2 weeks
|
0.00%
0/8 • 2 weeks
|
12.5%
1/8 • 2 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • 2 weeks
|
0.00%
0/8 • 2 weeks
|
25.0%
2/8 • 2 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • 2 weeks
|
0.00%
0/8 • 2 weeks
|
25.0%
2/8 • 2 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • 2 weeks
|
0.00%
0/8 • 2 weeks
|
12.5%
1/8 • 2 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/8 • 2 weeks
|
0.00%
0/8 • 2 weeks
|
12.5%
1/8 • 2 weeks
|
|
Eye disorders
Eye pruritus
|
0.00%
0/8 • 2 weeks
|
0.00%
0/8 • 2 weeks
|
12.5%
1/8 • 2 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/8 • 2 weeks
|
0.00%
0/8 • 2 weeks
|
12.5%
1/8 • 2 weeks
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/8 • 2 weeks
|
0.00%
0/8 • 2 weeks
|
12.5%
1/8 • 2 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8 • 2 weeks
|
25.0%
2/8 • 2 weeks
|
12.5%
1/8 • 2 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • 2 weeks
|
0.00%
0/8 • 2 weeks
|
12.5%
1/8 • 2 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • 2 weeks
|
12.5%
1/8 • 2 weeks
|
0.00%
0/8 • 2 weeks
|
Additional Information
Clinical Leader
Janssen Research & Development, LLC, Titusville, NJ
Phone: 609-730-3174
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator agrees that before he/she publishes any results of this trial he/she shall allow at least 45 days for the Sponsor to review the pre-publication manuscript prior to submission of the manuscript to the Publisher. In accordance with generally recognized principles of scientific collaboration, co-authorship with any company personnel will be discussed and mutually agreed upon before submission of the manuscript to the Publisher.
- Publication restrictions are in place
Restriction type: OTHER