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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by PharmaEssentia.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
PharmaEssentia Identifier:
First received: April 26, 2012
Last updated: April 27, 2012
Last verified: April 2012

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.

Condition Intervention Phase
Hepatitis C, Chronic
Biological: Pegasys
Biological: P1101, 48 doses
Biological: P1101, 24 doses
Biological: P1101, 12 doses
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by PharmaEssentia:

Primary Outcome Measures:
  • Sustained Virologic Response [ Time Frame: Follow up week 24 across treatment groups ] [ Designated as safety issue: No ]
    Percentage of subjects with sustained virologic response (SVR, undetectable HCV RNA at follow up week 24) across treatment groups.

Estimated Enrollment: 208
Study Start Date: October 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pegasys
Pegasys(subcutaneous injection)+Ribavirin, multiple doses(48)
Biological: Pegasys
48 doses, solution, 48 weeks
Experimental: P1101, 48 doses
P1101(subcutaneous injection)with Ribavirin, multiple doses
Biological: P1101, 48 doses
48 doses, solution, 48 weeks
Experimental: P1101, 24 doses
P1101(subcutaneous injection)+Ribavirin, multiple doses
Biological: P1101, 24 doses
24 doses, solution, 48 weeks
Experimental: P1101, 12 doses
P1101(subcutaneous injection)+Ribavirin, multiple doses
Biological: P1101, 12 doses
12 doses, solution, 48 weeks


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults ≥18 years of age ( ≥20 years for subjects enrolled in Taiwan);
  • Confirmed diagnosis of chronic hepatitis C (CHC) virus genotype 1 infection;
  • Compensated liver disease: with normal or elevated ALT/AST, no evidence of cirrhosis or portal hypertension as identified by ultrasound or any other procedures within 6 months before study entry;
  • Treatment naïve
  • No other form of chronic liver disease apart from chronic hepatitis C infection;
  • Hematology and renal biochemistry should be in definded ranges;
  • Be able to attend all scheduled visits and to comply with all study procedures;
  • Be able to provide written informed consent.

Exclusion Criteria:

  • Positive test for hepatitis B surface antigen (HBsAg) or human immunodeficiency virus (HIV) at screening;
  • Pregnancy or, in women of child-bearing potential or in spouses of such women, unwillingness or inability to practice adequate contraception;
  • Inability to comprehend the written consent form;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01587586

Contact: Ting-Fang Wang, MS/MHA +886 2 26557688 ext 7814
Contact: Ching-Leou Teng, Ph.D. +886 2 26557688 ext 7801

National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Sponsors and Collaborators
Principal Investigator: Ding-Shinn Chen, MD National Taiwan University Hospital
  More Information

Responsible Party: PharmaEssentia Identifier: NCT01587586     History of Changes
Other Study ID Numbers: A11-201 
Study First Received: April 26, 2012
Last Updated: April 27, 2012
Health Authority: United States: Food and Drug Administration
Taiwan: Food and Drug Administration, Department of Health, Executive Yuan

Keywords provided by PharmaEssentia:
Hepatitis C, Chronic
Hepatitis C Virus

Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic
Digestive System Diseases
Flaviviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections
Virus Diseases
Anti-Infective Agents
Antiviral Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on May 26, 2016