NCT02057887

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 8, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 7, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Last Updated

February 7, 2014

Status Verified

February 1, 2014

Enrollment Period

1.1 years

First QC Date

August 8, 2013

Last Update Submit

February 6, 2014

Conditions

Chronic Hepatitis C Virus Genotype I

Outcome Measures

Primary Outcomes (2)

  • HCV RNA Viral load

    Through study week 32

  • 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

Secondary Outcomes (3)

  • Rapid virologic response (RVR)

    Study Week 4

  • Early virologic response (EVR)

    Study week 12

  • Sustained virologic response (SVR)

    Study week 24

Study Arms (4)

Cohort1

EXPERIMENTAL

HM10660A SC once weekly

Drug: HM10660A

Cohort2

EXPERIMENTAL

HM10660A SC once every 2 weeks

Drug: HM10660A

Cohort3

EXPERIMENTAL

HM10660A SC once every 4 weeks

Drug: HM10660A

Cohort4

ACTIVE COMPARATOR

180 mcg Pegasys SC once weekly

Drug: Pegasys

Interventions

HM10660ADRUG
Also known as: Laps-IFNa
Cohort1Cohort2Cohort3
PegasysDRUG

180 mcg Pegasys SC once weekly

Cohort4

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanmi Clinical

Estado de México, State of Mexico, Mexico

RECRUITING

MeSH Terms

Interventions

peginterferon alfa-2a

Central Study Contacts

Hanmi Clinical

CONTACT

clinical4@hanmi.co.kr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2013

First Posted

February 7, 2014

Study Start

July 1, 2013

Primary Completion

August 1, 2014

Last Updated

February 7, 2014

Record last verified: 2014-02

Locations

ME(1)