Trial Outcomes & Findings for Open-Label, Bridging Study of Telaprevir in Treatment-Naïve and Treatment-Experienced Russian Patients With Genotype 1 Chronic Hepatitis C (NCT NCT01498068)
NCT ID: NCT01498068
Last Updated: 2015-01-30
Results Overview
A eRVR is defined as having hepatitis C virus (HCV) ribonucleic acid (RNA) less than 25 IU/mL, (target not detected) at Weeks 4 and 12 of treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
36 participants
Primary outcome timeframe
Week 4 and Week 12
Results posted on
2015-01-30
Participant Flow
The study was conducted at 5 sites in Russia.
Of the 39 participants screened, 36 participants (16 treatment-naïve/ 20 treatment-experienced) were enrolled and treated.
Participant milestones
| Measure |
Treatment-naïve
Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
|
Treatment-experienced
Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
20
|
|
Overall Study
COMPLETED
|
15
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Treatment-naïve
Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
|
Treatment-experienced
Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Open-Label, Bridging Study of Telaprevir in Treatment-Naïve and Treatment-Experienced Russian Patients With Genotype 1 Chronic Hepatitis C
Baseline characteristics by cohort
| Measure |
Treatment-naïve
n=16 Participants
Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
|
Treatment-experienced
n=20 Participants
Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<= 45 years
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Customized
Between 45 and 65 years
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Customized
> 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 4 and Week 12Population: Full analysis (FA) population: All participants who received at least one dose of the study medication.
A eRVR is defined as having hepatitis C virus (HCV) ribonucleic acid (RNA) less than 25 IU/mL, (target not detected) at Weeks 4 and 12 of treatment.
Outcome measures
| Measure |
Treatment-naïve
n=16 Participants
Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
|
Treatment-experienced
n=20 Participants
Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
|
|---|---|---|
|
Number of Participants With Extended Rapid Virologic Response (eRVR)
|
13 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 32, Week 40, and Week 48Population: Full analysis (FA) population: All participants who received at least one dose of the study medication. "n" signifies number of participants who were evaluable at each specified timepoint for each arm, respectively.
Changes from baseline in log10 HCV RNA levels were calculated.
Outcome measures
| Measure |
Treatment-naïve
n=16 Participants
Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
|
Treatment-experienced
n=20 Participants
Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
|
|---|---|---|
|
Median Change in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
Baseline (n=16, 20)
|
6.20 Log 10 IU/mL
Interval 4.6 to 6.9
|
6.10 Log 10 IU/mL
Interval 5.7 to 7.0
|
|
Median Change in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
Week 4 (n=16, 20)
|
-5.47 Log 10 IU/mL
Interval -6.2 to -3.9
|
-5.33 Log 10 IU/mL
Interval -6.3 to -3.5
|
|
Median Change in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
Week 8 (n=16,19)
|
-5.50 Log 10 IU/mL
Interval -6.2 to -3.9
|
-5.39 Log 10 IU/mL
Interval -6.3 to -5.0
|
|
Median Change in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
Week 12 (n=15,19)
|
-5.46 Log 10 IU/mL
Interval -6.2 to -3.9
|
-5.39 Log 10 IU/mL
Interval -6.3 to -5.0
|
|
Median Change in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
Week 24 (n=14, 19)
|
-5.53 Log 10 IU/mL
Interval -6.2 to -3.9
|
-5.39 Log 10 IU/mL
Interval -6.3 to -0.6
|
|
Median Change in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
Week 32 (n=2, 12)
|
-5.30 Log 10 IU/mL
Interval -5.5 to -5.1
|
-5.46 Log 10 IU/mL
Interval -6.3 to -5.2
|
|
Median Change in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
Week 40 (n=2, 12)
|
-5.30 Log 10 IU/mL
Interval -5.5 to -5.1
|
-5.46 Log 10 IU/mL
Interval -6.3 to -5.2
|
|
Median Change in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
Week 48 (n=2, 12)
|
-3.14 Log 10 IU/mL
Interval -5.1 to -1.2
|
-5.46 Log 10 IU/mL
Interval -6.3 to -5.2
|
SECONDARY outcome
Timeframe: Week 4Population: Full analysis (FA) population: All participants who received at least one dose of the study medication.
A RVR is defined as having hepatitis C virus (HCV) ribonucleic acid (RNA) less than 25 IU/mL, (target not detected) at Week 4
Outcome measures
| Measure |
Treatment-naïve
n=16 Participants
Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
|
Treatment-experienced
n=20 Participants
Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
|
|---|---|---|
|
Number of Participants With Rapid Virologic Response (RVR) at Week 4
|
14 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Weeks 8, 12, 24, 32, 40 and 48Population: Full analysis (FA) population: All participants who received at least one dose of the study medication. "n" signifies number of participants who were evaluable at each specified timepoint for each arm, respectively.
The table below shows number of participants with HCV RNA Less than 25 IU/mL, (target not detected) at Weeks 8, 12, 24, 32, 40 and 48. Only 3 treatment-naive and 14 Treatment-experienced participants were assigned to receive study treatment after Week 24. Only participants still receiving Treatment were assessed at 32, 40, and 48 weeks.
Outcome measures
| Measure |
Treatment-naïve
n=16 Participants
Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
|
Treatment-experienced
n=20 Participants
Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
|
|---|---|---|
|
Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Less Than 25 IU/mL, (Target Not Detected) at Weeks 8, 12, 24, 32, 40 and 48
Week 8 (n=16, 20)
|
16 Participants
|
19 Participants
|
|
Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Less Than 25 IU/mL, (Target Not Detected) at Weeks 8, 12, 24, 32, 40 and 48
Week 12 (n=16, 20)
|
15 Participants
|
19 Participants
|
|
Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Less Than 25 IU/mL, (Target Not Detected) at Weeks 8, 12, 24, 32, 40 and 48
Week 24 (n=16, 20)
|
15 Participants
|
18 Participants
|
|
Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Less Than 25 IU/mL, (Target Not Detected) at Weeks 8, 12, 24, 32, 40 and 48
Week 32 (n=3, 14)
|
2 Participants
|
12 Participants
|
|
Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Less Than 25 IU/mL, (Target Not Detected) at Weeks 8, 12, 24, 32, 40 and 48
Week 40 (n=3, 14)
|
2 Participants
|
12 Participants
|
|
Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Less Than 25 IU/mL, (Target Not Detected) at Weeks 8, 12, 24, 32, 40 and 48
Week 48 (n=3, 14)
|
1 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 32, or Week 40Population: Full analysis (FA) population: All participants who received at least one dose of the study medication.
Virologic failure is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels more than 1,000 IU/mL at Weeks 4, 8, 12, 24, 32, or 40.
Outcome measures
| Measure |
Treatment-naïve
n=16 Participants
Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
|
Treatment-experienced
n=20 Participants
Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
|
|---|---|---|
|
Number of Participants With Virologic Failure
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From Day 1 (Baseline) up to Follow-up visit (Week 36 or Week 60)Population: Full analysis (FA) population: All participants who received at least one dose of the study medication.
Participants were evaluated for following 4 categories of treatment outcome;Sustained Virologic Response 12 Weeks After Last Planned Dose of Study Medication(SVR12):hepatitis C virus (HCV)ribonucleic acid (RNA)\<25 IU/mL(target not detected)12 weeks after last planned dose of study medication;Relapse:HCV RNA =\>25 IU/mL during follow-up period after previous HCV RNA\<25 IU/mL at planned end of treatment(EOT)\[Week 24 or Week 48\] and participant did not achieve SVR12planned;On treatment virologic failure:meeting virologic stopping rule and/or having detectable HCV RNA at EOT with viral breakthrough(having a confirmed increase \>1 log 10 in HCV RNA level from the lowest level reached or confirmed value of HCV RNA \>100 IU/mL in participants whose HCV RNA has previously become \<25 IU/mL during treatment).Stopping rule defined as HCV RNA value \>1000 IU/mL at Week 4, 8 or 12 or detectable HCV RNA at Week 24, 32 or 40;Other:HCV RNA \<25 IU/mL at actual EOT and never HCV RNA =\>25 IU/mL thereafter.
Outcome measures
| Measure |
Treatment-naïve
n=16 Participants
Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
|
Treatment-experienced
n=20 Participants
Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
|
|---|---|---|
|
Number of Participants in Each Specific Category of Treatment Outcome
SVR12
|
14 Participants
|
16 Participants
|
|
Number of Participants in Each Specific Category of Treatment Outcome
Relapse
|
0 Participants
|
1 Participants
|
|
Number of Participants in Each Specific Category of Treatment Outcome
On treatment virologic failure
|
1 Participants
|
2 Participants
|
|
Number of Participants in Each Specific Category of Treatment Outcome
Other
|
1 Participants
|
1 Participants
|
Adverse Events
Treatment-naïve
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Treatment-experienced
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment-naïve
n=16 participants at risk
Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
|
Treatment-experienced
n=20 participants at risk
Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
|
|---|---|---|
|
General disorders
Influenza like illness
|
37.5%
6/16 • 60 weeks
|
45.0%
9/20 • 60 weeks
|
|
General disorders
Pyrexia
|
37.5%
6/16 • 60 weeks
|
15.0%
3/20 • 60 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
37.5%
6/16 • 60 weeks
|
30.0%
6/20 • 60 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.5%
2/16 • 60 weeks
|
20.0%
4/20 • 60 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.5%
2/16 • 60 weeks
|
5.0%
1/20 • 60 weeks
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
2/16 • 60 weeks
|
10.0%
2/20 • 60 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
6.2%
1/16 • 60 weeks
|
5.0%
1/20 • 60 weeks
|
|
Investigations
Blood uric acid increased
|
12.5%
2/16 • 60 weeks
|
0.00%
0/20 • 60 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.2%
1/16 • 60 weeks
|
5.0%
1/20 • 60 weeks
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/16 • 60 weeks
|
10.0%
2/20 • 60 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
4/16 • 60 weeks
|
10.0%
2/20 • 60 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
4/16 • 60 weeks
|
0.00%
0/20 • 60 weeks
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • 60 weeks
|
10.0%
2/20 • 60 weeks
|
|
Gastrointestinal disorders
Anal pruritus
|
0.00%
0/16 • 60 weeks
|
10.0%
2/20 • 60 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.8%
3/16 • 60 weeks
|
0.00%
0/20 • 60 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/16 • 60 weeks
|
10.0%
2/20 • 60 weeks
|
|
General disorders
Injection site erythema
|
6.2%
1/16 • 60 weeks
|
5.0%
1/20 • 60 weeks
|
|
General disorders
Asthenia
|
31.2%
5/16 • 60 weeks
|
15.0%
3/20 • 60 weeks
|
Additional Information
Compound Development Team Leader
Janssen Belgium
Phone: 32 14 64 13 70
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60