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

Tracking Information
First Received Date ^ICMJE	September 1, 2010
Last Updated Date	April 2, 2012
Start Date ^ICMJE	June 2011
Estimated Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 1, 2010)	HCV RNA level [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01194037 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 1, 2010)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Chronic Hepatitis C Infection Genotype 1
Intervention ^ICMJE	Drug: recombinant variant of interferon-alpha 2b SC, Weekly Other Name: Hanferon Drug: Peginterferon alfa-2a SC Weekly Other Name: Pegasys
Study Arm (s)	Experimental: Hanferon (low dose) sc weekly + RBV oral daily Intervention: Drug: recombinant variant of interferon-alpha 2b Experimental: Hanferon (high dose) sc weekly + RBV oral daily Intervention: Drug: recombinant variant of interferon-alpha 2b Active Comparator: Pegasys 180 ug sc weekly + RBV oral daily Intervention: Drug: Peginterferon alfa-2a
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	30
Estimated Completion Date	June 2012
Estimated Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01194037
Other Study ID Numbers ^ICMJE	HL-143IFN-SC-US-001
Has Data Monitoring Committee	No
Responsible Party	HanAll BioPharma Co., Ltd.
Study Sponsor ^ICMJE	HanAll BioPharma Co., Ltd.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	HanAll BioPharma Co., Ltd.
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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