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Dose Finding Study of Pegylated-P-Interferon-alpha-2b(P1101) in Treatment-Naive Subjects With Hepatitis C Virus Genotype 1 Infection

NCT01587586 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2021-10-15

No results posted yet for this study

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

  • Hepatitis C, Chronic

Interventions

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

Sponsors & Collaborators

  • PharmaEssentia

    lead INDUSTRY

Principal Investigators

  • Kuan-Chiao Tseng, MD, Sc.D. · PharmaEssentia Corp.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-18
Primary Completion
2016-11-22
Completion
2016-11-22

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01587586 on ClinicalTrials.gov