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

Chronic Hepatitis C Virus Genotype I Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02057887
• Other study ID #: HM-IFN-201
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: August 8, 2013
• Last updated: February 6, 2014
• Start date: July 2013

Study information

• Verified date: February 2014
• Source: Hanmi Pharmaceutical Company Limited
• Contact: Hanmi Clinical
• Email: clinical4[@]hanmi.co.kr
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks Protection
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C Virus Genotype I
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• HM10660A

• Pegasys
180 mcg Pegasys SC once weekly

Locations

Country	Name	City	State
Mexico	Hanmi Clinical	Estado de Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCV RNA Viral load		Through study week 32	No
Primary	Safety/tolerability	symptom-directed physical examination, Vital signs, Inspection of the Injection site, Complete Physical examination, 12-lead ECG, Hematology/coagulation	Through study week 32	Yes
Secondary	Rapid virologic response (RVR)		Study Week 4	No
Secondary	Early virologic response (EVR)		Study week 12	No
Secondary	Sustained virologic response (SVR)		Study week 24	No