We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 1b/2a, Open-label,Randomized, Safety, Tolerability, Dose Finding, PK/PD, and Preliminary Efficacy Study of SC Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01194037
First Posted: September 2, 2010
Last Update Posted: February 25, 2014
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):
HanAll BioPharma Co., Ltd.
  Purpose
The primary objective of this study is to evaluate the safety and tolerability of ascending doses of Hanferon™ in combination with ribavirin (RBV). The secondary objective of this study is to define the PK and PD of ascending doses of Hanferon™ in combination with RBV. The exploratory objective of this study is to make a preliminary assessment of Hanferon™ efficacy in combination with RBV.

Condition Intervention Phase
Chronic Hepatitis C Infection Genotype 1 Drug: recombinant variant of interferon-alpha 2b Drug: Peginterferon alfa-2a Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b/2a, Open-label,Randomized, Safety, Tolerability, Dose Finding, Pharmacokinetic/Pharmacodynamic, and Preliminary Efficacy Study of Subcutaneous Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C

Resource links provided by NLM:


Further study details as provided by HanAll BioPharma Co., Ltd.:

Primary Outcome Measures:
  • HCV RNA level [ Time Frame: Week 4 ]

Secondary Outcome Measures:
  • Proportion of patients who reach RVR [ Time Frame: Week 4 ]
  • PK & PD [ Time Frame: Weeks 0 and 3 ]

Enrollment: 30
Study Start Date: June 2011
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hanferon (low dose) sc weekly + RBV oral daily Drug: recombinant variant of interferon-alpha 2b
SC, Weekly
Other Name: Hanferon
Experimental: Hanferon (high dose) sc weekly + RBV oral daily Drug: recombinant variant of interferon-alpha 2b
SC, Weekly
Other Name: Hanferon
Active Comparator: Pegasys 180 ug sc weekly + RBV oral daily Drug: Peginterferon alfa-2a
SC Weekly
Other Name: Pegasys

  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 to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of chronic hepatitis C genotype 1a or 1b
  • Male or female aged 18 to 65 years, inclusive
  • Compensated liver disease without evidence of cirrhosis
  • No evidence of type 1 or 2 diabetes mellitus, lipodystrophy or polycystic ovary syndrome
  • No history or presence of autoimmune or lymphoproliferative disease or hemoglobinopathies
  • Stable medication doses for 1 month for the chronic disease if subjects have chronic diseases, including but not limited to hypertension and dyslipidemia

Exclusion Criteria:

  • History of previous treatment of hepatitis C
  • Currently use medication for psychiatric illness including depression, suicidal ideation, and psychosis
  • History or presence of chronic liver disease
  • History of drug or alcohol abuse within the past year
  • Evidence of active illicit drug use
  • Clinically significant abnormal electrocardiogram (ECG) or rhythm strip
  • Female subject who has a positive urine pregnancy test or who is lactating
  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): NCT01194037


Locations
United States, California
Los Angeles, California, United States, 90036
National City, California, United States
United States, Florida
Miami, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Kentucky
Lexington, Kentucky, United States
United States, Louisiana
New Orleans, Louisiana, United States
Sponsors and Collaborators
HanAll BioPharma Co., Ltd.
  More Information

Responsible Party: HanAll BioPharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT01194037     History of Changes
Other Study ID Numbers: HL-143IFN-SC-US-001
First Submitted: September 1, 2010
First Posted: September 2, 2010
Last Update Posted: February 25, 2014
Last Verified: February 2014

Keywords provided by HanAll BioPharma Co., Ltd.:
Hepatitis C
HCV
Interferon
Hanferon

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
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