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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. The completion date has passed and the status has not been verified in more than two years.
Verified April 2012 by PharmaEssentia.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01587586
First Posted: April 30, 2012
Last Update Posted: April 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
PharmaEssentia
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: PharmaEssentia
ClinicalTrials.gov Identifier: NCT01587586     History of Changes
Other Study ID Numbers: A11-201
First Submitted: April 26, 2012
First Posted: April 30, 2012
Last Update Posted: April 30, 2012
Last Verified: April 2012

Keywords provided by PharmaEssentia:
Hepatitis C, Chronic
Interferon-alpha
Hepatitis C Virus

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Interferons
Ribavirin
Interferon-alpha
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs