Back to resultsSafety,Tolerability and Pharmacokinetic Study of Recombinant Human Interferon Alfa 2B in Chronic Hepatitis C Patients (HM10660A)
Primary Purpose
Chronic Hepatitis C Virus Genotype I
Status
Unknown status
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
HM10660A
Pegasys
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C Virus Genotype I
Eligibility Criteria
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
Sites / Locations
- Hanmi ClinicalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Cohort1
Cohort2
Cohort3
Cohort4
Arm Description
HM10660A SC once weekly
HM10660A SC once every 2 weeks
HM10660A SC once every 4 weeks
180 mcg Pegasys SC once weekly
Outcomes
Primary Outcome Measures
HCV RNA Viral load
Safety/tolerability
symptom-directed physical examination, Vital signs, Inspection of the Injection site, Complete Physical examination, 12-lead ECG, Hematology/coagulation
Secondary Outcome Measures
Rapid virologic response (RVR)
Early virologic response (EVR)
Sustained virologic response (SVR)
Full Information
NCT ID
NCT02057887
First Posted
August 8, 2013
Last Updated
February 6, 2014
Sponsor
Hanmi Pharmaceutical Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT02057887
Brief Title
Safety,Tolerability and Pharmacokinetic Study of Recombinant Human Interferon Alfa 2B in Chronic Hepatitis C Patients (HM10660A)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited
4. Oversight
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C Virus Genotype I
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort1
Arm Type
Experimental
Arm Description
HM10660A SC once weekly
Arm Title
Cohort2
Arm Type
Experimental
Arm Description
HM10660A SC once every 2 weeks
Arm Title
Cohort3
Arm Type
Experimental
Arm Description
HM10660A SC once every 4 weeks
Arm Title
Cohort4
Arm Type
Active Comparator
Arm Description
180 mcg Pegasys SC once weekly
Intervention Type
Drug
Intervention Name(s)
HM10660A
Other Intervention Name(s)
Laps-IFNa
Intervention Type
Drug
Intervention Name(s)
Pegasys
Intervention Description
180 mcg Pegasys SC once weekly
Primary Outcome Measure Information:
Title
HCV RNA Viral load
Time Frame
Through study week 32
Title
Safety/tolerability
Description
symptom-directed physical examination, Vital signs, Inspection of the Injection site, Complete Physical examination, 12-lead ECG, Hematology/coagulation
Time Frame
Through study week 32
Secondary Outcome Measure Information:
Title
Rapid virologic response (RVR)
Time Frame
Study Week 4
Title
Early virologic response (EVR)
Time Frame
Study week 12
Title
Sustained virologic response (SVR)
Time Frame
Study week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanmi Clinical
Email
clinical4@hanmi.co.kr
Facility Information:
Facility Name
Hanmi Clinical
City
Estado de Mexico
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanmi Clinical
Email
clinical4@hanmi.co.kr
12. IPD Sharing Statement
Learn more about this trial
Safety,Tolerability and Pharmacokinetic Study of Recombinant Human Interferon Alfa 2B in Chronic Hepatitis C Patients (HM10660A)
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