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

February 6, 2014 updated by: Hanmi Pharmaceutical Company Limited
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Estado de Mexico, Mexico
        • Recruiting
        • Hanmi Clinical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cohort1
HM10660A SC once weekly
Drug: HM10660A
Other Names:
  • Laps-IFNa
EXPERIMENTAL: Cohort2
HM10660A SC once every 2 weeks
Drug: HM10660A
Other Names:
  • Laps-IFNa
EXPERIMENTAL: Cohort3
HM10660A SC once every 4 weeks
Drug: HM10660A
Other Names:
  • Laps-IFNa
ACTIVE_COMPARATOR: Cohort4
180 mcg Pegasys SC once weekly
Drug: Pegasys
180 mcg Pegasys SC once weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HCV RNA Viral load
Time Frame: Through study week 32
Through study week 32
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
Through study week 32

Secondary Outcome Measures

Outcome Measure
Time Frame
Rapid virologic response (RVR)
Time Frame: Study Week 4
Study Week 4
Early virologic response (EVR)
Time Frame: Study week 12
Study week 12
Sustained virologic response (SVR)
Time Frame: Study week 24
Study week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ANTICIPATED)

August 1, 2014

Study Registration Dates

First Submitted

August 8, 2013

First Submitted That Met QC Criteria

February 6, 2014

First Posted (ESTIMATE)

February 7, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 7, 2014

Last Update Submitted That Met QC Criteria

February 6, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-IFN-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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