Trials / Completed
CompletedNCT01587586
Dose Finding Study of Pegylated-P-Interferon-alpha-2b(P1101) in Treatment-Naive Subjects With Hepatitis C Virus Genotype 1 Infection
An Open-label, Randomized, Active Control Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of P1101 + Ribavirin in Treatment-Naïve Subjects With HCV Genotype 1 Infection
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 107 (actual)
- Sponsor
- PharmaEssentia · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Primary objectives: The purpose of this study is to determine and compare the sustained virologic response (SVR, undetectable HCV RNA at Follow up week 24 (FW24)) across treatment groups. To determine and compare the safety and tolerability of P1101 + Ribavirin across treatment groups.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PEGASYS 180 µg Q1W | 48 doses, solution, 48 weeks |
| BIOLOGICAL | P1101 180 µg Q1W, 48 doses | 48 doses, solution, 48 weeks |
| BIOLOGICAL | P1101 270µg Q1W, 48 doses | 48 doses, solution, 48 weeks |
| BIOLOGICAL | P1101 450µg Q2W, 24 doses | 24 doses, solution, 48 weeks |
Timeline
- Start date
- 2011-10-18
- Primary completion
- 2016-11-22
- Completion
- 2016-11-22
- First posted
- 2012-04-30
- Last updated
- 2021-10-15
Locations
13 sites across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT01587586. Inclusion in this directory is not an endorsement.