Trial · NCT01204762
Dose Ranging Study of Pegylated Interferon Lambda in Patients With Hepatitis B and Positive for the Hepatitis B e Antigen
NCT01204762, Phase 2, Completed, Bristol-Myers Squibb
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dose Ranging Study of Pegylated Interferon Lambda in Patients With Hepatitis B and Positive for the Hepatitis B e Antigen. Trials, record NCT01204762. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01204762
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose Ranging Study of Pegylated Interferon Lambda in Patients With Hepatitis B and Positive for the Hepatitis B e Antigen
- NCT number
- NCT01204762
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 197 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Hepatitis B Virus
- Interventions
- pegIFN, pegIFNα-2a, PegIFN lambda, Entecavir
- First posted
- 2010-09-17
- Last updated
- 2015-10-09
- Other registries' IDs
- eudract:2010-020387-38
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: Proportion of subjects who achieve Hepatitis B e antigen (HBeAg) seroconversion | 24 weeks post-dosing (Week 72) | |
| Primary | Part A: Number and percent of subjects with serious adverse events (SAEs) and discontinuations due to adverse events | Week 24 | |
| Primary | Part A: Number and percent of subjects with serious adverse events (SAEs) and discontinuations due to adverse events | 24 weeks post-dosing (Week 72) | |
| Primary | Part B: Safety and tolerability of Lambda/ETV regimen as measured by the frequency of SAEs and discontinuations due to AEs | Up to 84 Weeks | |
| Secondary | Part A: Proportion of subjects who achieve an hepatitis B virus Deoxyribonucleic acid levels (HBV DNA) < 50 IU/mL (approximately 300 copies/mL) using the Roche COBAS® TaqMan - High Pure System (HPS) assay | Weeks 24, 48, 72, 96, 120, 144, 168 and 192 | |
| Secondary | Part A: Mean change from baseline in log10 HBV DNA levels over time (Proportion of subjects with Alanine amino transferase (ALT) normalization (≤ 1 x upper limit of normal (ULN)) | Baseline (Day 1), Weeks 24, 48, 72, 96, 120, 144, 168 and 192 | |
| Secondary | Part A: Proportion of subjects with ALT normalization (≤ 1 x ULN) | Weeks 24, 48, 72, 96, 120, 144, 168 and 192 | |
| Secondary | Part A: Hepatitis E antigen (HBeAg) loss | Weeks 24, 48, 72, 96, 120, 144, 168 and 192 | |
| Secondary | Part A: HBeAg seroconversion | Weeks 24, 48, 96, 120, 144, 168 and 192 | |
| Secondary | Part A: Mean change from baseline in log10 quantitative HBeAg levels over time | Baseline (Day 1), Weeks 24, 48, 96, 120, 144, 168 and 192 |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01204762
GET https://conductscience.org/api/trials/v1/NCT01204762/registered?page=2