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

April 26, 2012
April 27, 2012
October 2011
December 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01587586 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Dose Finding Study of Pegylated-P-Interferon-alpha-2b(P1101) in Treatment-Naive Subjects With HCV 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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Biological: Pegasys
    48 doses, solution, 48 weeks
  • Biological: P1101, 48 doses
    48 doses, solution, 48 weeks
  • Biological: P1101, 24 doses
    24 doses, solution, 48 weeks
  • Biological: P1101, 12 doses
    12 doses, solution, 48 weeks
  • Active Comparator: Pegasys
    Pegasys(subcutaneous injection)+Ribavirin, multiple doses(48)
    Intervention: Biological: Pegasys
  • Experimental: P1101, 48 doses
    P1101(subcutaneous injection)with Ribavirin, multiple doses
    Intervention: Biological: P1101, 48 doses
  • Experimental: P1101, 24 doses
    P1101(subcutaneous injection)+Ribavirin, multiple doses
    Intervention: Biological: P1101, 24 doses
  • Experimental: P1101, 12 doses
    P1101(subcutaneous injection)+Ribavirin, multiple doses
    Intervention: Biological: P1101, 12 doses
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
208
Not Provided
December 2013   (final data collection date for primary outcome measure)

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;
Both
18 Years and older
No
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
Taiwan
 
NCT01587586
A11-201
No
PharmaEssentia
PharmaEssentia
Not Provided
Principal Investigator: Ding-Shinn Chen, MD National Taiwan University Hospital
PharmaEssentia
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP