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
Sponsor:
Information provided by (Responsible Party):
PharmaEssentia
ClinicalTrials.gov Identifier:
NCT01587586
First received: April 26, 2012
Last updated: April 27, 2012
Last verified: April 2012
  Purpose

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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01587586

Contacts
Contact: Ting-Fang Wang, MS/MHA +886 2 26557688 ext 7814 tingfang_wang@pharmaessentia.com
Contact: Ching-Leou Teng, Ph.D. +886 2 26557688 ext 7801 chingleou_teng@pharmaessentia.com

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

No publications provided

Responsible Party: PharmaEssentia
ClinicalTrials.gov 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
Interferon-alpha
Hepatitis C Virus

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Interferon-alpha
Interferons
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 19, 2014