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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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
HanAll BioPharma Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01194037
First received: September 1, 2010
Last updated: April 2, 2012
Last verified: April 2012
History of Changes
  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: 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • HCV RNA level [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients who reach RVR [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • PK & PD [ Time Frame: Weeks 0 and 3 ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: June 2011
Estimated Study Completion Date: June 2012
Estimated 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: HanAll BioPharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT01194037     History of Changes
Other Study ID Numbers: HL-143IFN-SC-US-001
Study First Received: September 1, 2010
Last Updated: April 2, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on June 18, 2013