Trial · NCT04638439
The Safety and Efficacy of Sequential Treatment of Ropeginterferon Alfa-2b (P1101) and Anti-PD1 in Interferon-Naive Adults With Chronic Hepatitis B or D Infection
NCT04638439, Phase 1, Completed, PharmaEssentia
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Safety and Efficacy of Sequential Treatment of Ropeginterferon Alfa-2b (P1101) and Anti-PD1 in Interferon-Naive Adults With Chronic Hepatitis B or D Infection. Trials, record NCT04638439. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04638439
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Safety and Efficacy of Sequential Treatment of Ropeginterferon Alfa-2b (P1101) and Anti-PD1 in Interferon-Naive Adults With Chronic Hepatitis B or D Infection
- NCT number
- NCT04638439
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 20 participants, actual
- Lead sponsor
- PharmaEssentia
- Conditions
- Chronic Hepatitis B Infection, Chronic Hepatitis D Infection
- Interventions
- P1101 + Nivolumab + Entecavir
- First posted
- 2020-11-20
- Last updated
- 2026-06-10
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety: AE/SAE | Through study Follow-up Week 24 (up to 330 days) | Number of patients with adverse events, including SAEs |
| Primary | Safety: clinically significant abnormalities | Through study Follow-up Week 24 (up to 330 days) | Number of patients with clinically significant abnormalities, including vital sign, physical examination, electrocardiogram (ECG) and laboratory data |
| Secondary | Subjects with HBsAg loss | Treatment Week 12, Treatment Week 23, Follow-up Week 12 and Follow-up Week 24 | The percentage of subjects with HBsAg loss at treatment week 12, 23 and follow up week 12, 24 in the treatment group |
| Secondary | Subjects with HBsAg reduction from baseline | Treatment Week 12, Treatment Week 23, Follow-up Week 12 and Follow-up Week 24 | The percentage of subjects with HBsAg reduction from baseline at treatment week 12, 23 and follow up week 12, 24 in the treatment group |
| Secondary | Subjects with HBsAg seroconversion | Treatment Week 12, Treatment Week 23, Follow-up Week 12 and Follow-up Week 24 | The percentage of subjects with HBsAg seroconversion at treatment week 12, 23 and follow up week 12, 24 in the treatment group |
| Secondary | Subjects with undetectable HBV DNA | Treatment Week 12, Treatment Week 23, Follow-up Week 12 and Follow-up Week 24 | The percentage of subjects with undetectable HBV DNA at treatment week 12, 23 and follow up week 12, 24 in the treatment group |
| Secondary | Subjects with ≥ 2 log10 decline from baseline in HDV RNA | Treatment Week 12, Treatment Week 23, Follow-up Week 12 and Follow-up Week 24 | The percentage of subjects with ≥ 2 log10 decline from baseline in HDV RNA at treatment week 12, 23 and follow up week 12, 24 in the treatment group |
| Secondary | Subjects with undetectable HDV RNA | Treatment Week 12, Treatment Week 23, Follow-up Week 12 and Follow-up Week 24 | The percentage of subjects with undetectable HDV RNA at treatment week 12, 23 and follow up week 12, 24 in the treatment group |
| Secondary | Subjects with ALT normalization | Treatment Week 12, Treatment Week 23, Follow-up Week 12 and Follow-up Week 24 | The percentage of subjects with ALT normalization at treatment week 12, 23 and follow up week 12, 24 in the treatment group |
Source ClinicalTrials.gov
Outcomes0
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT04638439
GET https://conductscience.org/api/trials/v1/NCT04638439/registered