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Safety,Tolerability and Pharmacokinetic Study of Recombinant Human Interferon Alfa 2B in Chronic Hepatitis C Patients (HM10660A)

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. Identifier: NCT02057887
Recruitment Status : Unknown
Verified February 2014 by Hanmi Pharmaceutical Company Limited.
Recruitment status was:  Recruiting
First Posted : February 7, 2014
Last Update Posted : February 7, 2014
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of HM10660A in subjects with chronic hepatitis C(HCV).

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Virus Genotype I Drug: HM10660A Drug: Pegasys Phase 1 Phase 2

Detailed Description:
  • To evaluate the repeat-dose pharmacokinetics (PK) of HM10660A when given by weekly, biweekly, and monthly subcutaneous (SC) injection.
  • To evaluate the repeat-dose pharmacodynamics (PD) of HM10660A when given by weekly, biweekly, and monthly SC injection.
  • To explore the antiviral activity of HM10660A at Week 4, Week 12, and Week 24.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2013
Estimated Primary Completion Date : August 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Cohort1
HM10660A SC once weekly
Drug: HM10660A
Other Name: Laps-IFNa

Experimental: Cohort2
HM10660A SC once every 2 weeks
Drug: HM10660A
Other Name: Laps-IFNa

Experimental: Cohort3
HM10660A SC once every 4 weeks
Drug: HM10660A
Other Name: Laps-IFNa

Active Comparator: Cohort4
180 mcg Pegasys SC once weekly
Drug: Pegasys
180 mcg Pegasys SC once weekly

Primary Outcome Measures :
  1. HCV RNA Viral load [ Time Frame: Through study week 32 ]
  2. Safety/tolerability [ Time Frame: Through study week 32 ]
    symptom-directed physical examination, Vital signs, Inspection of the Injection site, Complete Physical examination, 12-lead ECG, Hematology/coagulation

Secondary Outcome Measures :
  1. Rapid virologic response (RVR) [ Time Frame: Study Week 4 ]
  2. Early virologic response (EVR) [ Time Frame: Study week 12 ]
  3. Sustained virologic response (SVR) [ Time Frame: Study week 24 ]

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.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female, aged 18 to 65 years old, inclusive
  • Willing and able to provide written informed consent.
  • Previously untreated HCV infection with HCV RNA > 75,000 IU/mL at screening.
  • HCV genotype 1a or 1b.
  • Body mass index (BMI) between 18 and 38 kg/m2.
  • Willing and able to comply with the protocol and available to complete the study schedule of assessments.

Exclusion Criteria:

  • Pregnant women or women who may wish to become pregnant during the course of the study.
  • Males and females of reproductive potential who are unwilling to use 2 forms of effective birth control throughout the duration of study treatment and for at least 6 months after the last dose of RBV. One method should include a condom with spermicide for males. Males must agree to refrain from sperm donation for at least 6 months after the last dose of RBV.
  • Evidence of infection or co-infection with a non-genotype 1 HCV strain.
  • Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
  • Lactating females

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 identifier (NCT number): NCT02057887

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Contact: Hanmi Clinical

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Hanmi Clinical Recruiting
Estado de Mexico, Mexico
Contact: Hanmi Clinical   
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
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Responsible Party: Hanmi Pharmaceutical Company Limited Identifier: NCT02057887    
Other Study ID Numbers: HM-IFN-201
First Posted: February 7, 2014    Key Record Dates
Last Update Posted: February 7, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents