Trials / Completed
CompletedNCT04638439
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
A Phase Ib, Open Label Study to Assess the Safety and Efficacy of Sequential Administration of P1101 and Anti-PD1 in Interferon-Naive Adults With Chronic Hepatitis B or D Infection
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- PharmaEssentia · Industry
- Sex
- All
- Age
- 20 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
Primary objective: To evaluate the safety and tolerability of sequential administration of P1101 and anti-PD1 in patient with chronic hepatitis B or D infection Secondary objectives: 1. To explore HBsAg loss and kinetics during the study period 2. To assess the anti-viral effect during the study period 3. To evaluate the rate of ALT normalization
Detailed description
There are 20 scheduled visits (screening, treatment weeks \& follow-up weeks) for patients which include screening visit, TW0 (baseline), TW2, TW4, TW6, TW8, TW10, TW12, TW13, TW15, TW17, TW19, TW21, TW23 (EOT), FW4, FW8, FW12, FW16, FW20 and FW24.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | P1101 + Nivolumab + Entecavir | P1101 (Ropeginterferon alfa-2b) 450 µg subcutaneously (SC) Q2W for 6 doses (12 weeks), followed by 0.3 mg/kg Nivolumab for 6 doses (12 weeks), with a follow up of 24 weeks. All patients will also receive Entecavir 0.5 mg QD from Day 1 to Follow-up 24. |
Timeline
- Start date
- 2022-08-17
- Primary completion
- 2025-05-14
- Completion
- 2025-05-14
- First posted
- 2020-11-20
- Last updated
- 2025-07-02
Locations
5 sites across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT04638439. Inclusion in this directory is not an endorsement.