Trial Outcomes & Findings for A Study of Peginterferon Alfa-2a in Participants With Chronic Hepatitis B Virus (HBV) in an Expanded Access Program (NCT NCT02791269)
NCT ID: NCT02791269
Last Updated: 2017-02-06
Results Overview
HBV-DNA was assessed in plasma samples using quantitative Roche polymerase chain reaction (PCR) or Taqman tests.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
24 participants
Primary outcome timeframe
End of 24-weeks follow-up (Week 72)
Results posted on
2017-02-06
Participant Flow
Participant milestones
| Measure |
HBeAg Negative Participants
Hepatitis B e antigen (HBeAg) negative participants received peginterferon alfa-2a 180 micrograms (mcg) subcutaneous (SC) injection once weekly (QW) for 48 weeks followed by a 24 weeks treatment-free follow-up period.
|
HBeAg Positive Participants
HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
20
|
|
Overall Study
COMPLETED
|
4
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
HBeAg Negative Participants
Hepatitis B e antigen (HBeAg) negative participants received peginterferon alfa-2a 180 micrograms (mcg) subcutaneous (SC) injection once weekly (QW) for 48 weeks followed by a 24 weeks treatment-free follow-up period.
|
HBeAg Positive Participants
HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
A Study of Peginterferon Alfa-2a in Participants With Chronic Hepatitis B Virus (HBV) in an Expanded Access Program
Baseline characteristics by cohort
| Measure |
HBeAg Negative Participants
n=4 Participants
HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
|
HBeAg Positive Participants
n=20 Participants
HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.25 years
STANDARD_DEVIATION 5.75 • n=5 Participants
|
31.57 years
STANDARD_DEVIATION 9.43 • n=7 Participants
|
33.52 years
STANDARD_DEVIATION 9.88 • n=5 Participants
|
|
Gender
Female
|
0 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Gender
Male
|
4 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of 24-weeks follow-up (Week 72)Population: Intent-to-treat (ITT) population included all participants who received at least one dose of study medication and had one subsequent post baseline assessment. Here, "number of participants analyzed" signified those participants who were evaluable for this outcome.
HBV-DNA was assessed in plasma samples using quantitative Roche polymerase chain reaction (PCR) or Taqman tests.
Outcome measures
| Measure |
HBeAg Positive Participants
n=17 Participants
HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
|
HBeAg Positive Participants
HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
|
|---|---|---|
|
Number of HBeAg Positive Participants With Hepatitis B Virus-deoxy Ribonucleic Acid (HBV-DNA) Less Than (<) 100,000 Copies Per Milliliter (Copies/mL)
|
7 participants
|
—
|
PRIMARY outcome
Timeframe: End of 24-weeks follow-up (Week 72)Population: ITT population. Here, "number of participants analyzed" signified those participants who were evaluable for this outcome.
HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests.
Outcome measures
| Measure |
HBeAg Positive Participants
n=3 Participants
HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
|
HBeAg Positive Participants
n=17 Participants
HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
|
|---|---|---|
|
Number of Participants With HBV-DNA <20,000 Copies/mL
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Week 48 (end of treatment) and Week 72 (end of follow-up)Population: ITT population. Here, "number of participants analyzed" signified those participants who were evaluable for this outcome and "n" signified participants with evaluable data for a specified time point.
HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests.
Outcome measures
| Measure |
HBeAg Positive Participants
n=4 Participants
HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
|
HBeAg Positive Participants
n=18 Participants
HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
|
|---|---|---|
|
Number of Participants With HBV-DNA <400 Copies/mL
Week 48 (n=4,18)
|
3 participants
|
6 participants
|
|
Number of Participants With HBV-DNA <400 Copies/mL
Week 72 (n=3,17)
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Week 48 (end of treatment) and Week 72 (end of follow-up)Population: ITT population. Here, "number of participants analyzed" signified those participants who were evaluable for this outcome and "n" signified participants with evaluable data for a specified time point.
HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs). Both HBeAg positive and negative participants were HBsAg positive at baseline and absence of HBsAg (seroconversion) was analyzed.
Outcome measures
| Measure |
HBeAg Positive Participants
n=4 Participants
HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
|
HBeAg Positive Participants
n=15 Participants
HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
|
|---|---|---|
|
Number of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion
Week 48 (n=4,15)
|
0 participants
|
0 participants
|
|
Number of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion
Week 72 (n=4,13)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 48 (end of treatment) and Week 72 (end of follow-up)Population: ITT population. Here, "number of participants analyzed" signified those participants who were evaluable for this outcome and "n" signified participants with evaluable data for a specified time point.
ALT is an enzyme found mainly in liver and is measured to check if the liver is damaged or diseased. In case of liver damage or disease, the liver releases ALT into the blood stream and the ALT level increases. Normal ALT level = less than upper limit of normal (40 units per liter).
Outcome measures
| Measure |
HBeAg Positive Participants
n=4 Participants
HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
|
HBeAg Positive Participants
n=19 Participants
HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
|
|---|---|---|
|
Number of Participants With Normalization of Alanine Aminotransferase (ALT) Level
Week 48 (n=4,19)
|
2 participants
|
4 participants
|
|
Number of Participants With Normalization of Alanine Aminotransferase (ALT) Level
Week 72 (n=4,17)
|
4 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Week 48 (end of treatment) and Week 72 (end of follow-up)Population: ITT population. Only HBeAg positive participants was planned to be reported. Here, "number of participants analyzed" signified those participants who were evaluable for this outcome and "n" signified participants with evaluable data for a specified time point.
HBeAg seroconversion for HBeAg positive participants was defined as the loss of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe).
Outcome measures
| Measure |
HBeAg Positive Participants
n=19 Participants
HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
|
HBeAg Positive Participants
HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
|
|---|---|---|
|
Number of Participants With HBeAg Seroconversion
Week 48 (n=19)
|
6 participants
|
—
|
|
Number of Participants With HBeAg Seroconversion
Week 72 (n=17)
|
6 participants
|
—
|
Adverse Events
HBeAg Negative Participants
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
HBeAg Positive Participants
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HBeAg Negative Participants
n=4 participants at risk
HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
|
HBeAg Positive Participants
n=20 participants at risk
HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
|
|---|---|---|
|
Cardiac disorders
chest pain
|
25.0%
1/4 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
0.00%
0/20 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
Other adverse events
| Measure |
HBeAg Negative Participants
n=4 participants at risk
HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
|
HBeAg Positive Participants
n=20 participants at risk
HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
|
|---|---|---|
|
Nervous system disorders
Depression
|
50.0%
2/4 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
5.0%
1/20 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
|
Nervous system disorders
Mood disturbance
|
25.0%
1/4 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
5.0%
1/20 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
|
General disorders
Tiredness
|
25.0%
1/4 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
5.0%
1/20 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
0.00%
0/20 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Itchy skin
|
0.00%
0/4 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
5.0%
1/20 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
5.0%
1/20 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
|
Eye disorders
Glaucoma
|
0.00%
0/4 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
5.0%
1/20 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
|
Eye disorders
Eye infection
|
0.00%
0/4 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
5.0%
1/20 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Non-productive cough
|
25.0%
1/4 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
0.00%
0/20 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/4 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
5.0%
1/20 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
|
Reproductive system and breast disorders
Blood in semen
|
0.00%
0/4 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
5.0%
1/20 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
0.00%
0/4 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
5.0%
1/20 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
0.00%
0/20 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
|
Renal and urinary disorders
Urinary frequency
|
25.0%
1/4 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
0.00%
0/20 • Baseline up to end of follow-up period (Approximately 72 weeks)
Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER