Hepatitis C
Conditions
Keywords
Hepatitis C naive
Brief summary
This is an open label, dose ranging, phase1a/1b clinical trial to study the safety, Pharmacokinetics and Pharmacodynamics of Peglamda 60, 120, 180 and 240 mcg in healthy volunteers and antiviral activity of once weekly Peglamda administration in combination with daily Ribavirin in Hepatitis C naive patients up to 4 weeks period. The objective of the study to establish safety, PK/PD data on healthy subjects and preliminary efficacy and safety in Hepatitis C naive patients.
Interventions
BIOLOGICALPeginterferon lambda
Sponsors
Nanogen Pharmaceutical Biotechnology Joint Stock Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Phase 1a: The subjects who are willing to participate in Phase 1a study must meet ALL of the following inclusion criteria: 1. Volunteers (male and female) between the ages of 18-45 2. Women have a negative pregnancy test result at the time of study. 3. Clinical examination and result laboratory for 7 days before starting the trial must be inside the normal range. 4. Currently not following any treatment regimen (except for using the oral contraceptive). 5. Body mass index is between the range and / or not 25% difference compared to the normal BMI (Appendix 6). 6. Be able to comply with protocol and exchange information effectively with the researchers, agree on the written informed consent to participate in the clinical trial Phase 1b: Subjects willing to participate into the phase 1b study must meet ALL of the following inclusion criteria: 1. Patients with chronic hepatitis C (male and female). 2. Ages between 18 - 65 years old. 3. Female patient (or female partners of the male patients) with negative pregnancy test results and/or apply effective contraception if still having sex during the study and for 6 months after using the last dose of Ribavirin. 4. No previous treatment with IFN or IFN treatment with rapid viral response or already have completely viral response but leave the treatment early. 5. HCV-RNA levels in serum \> 80 IU / mL. 6. The haematological and biochemical (except ALT / AST) parameters must be within normal limits. 7. Body weight in the normal range of 25% difference compared to the normal BMI (Appendix 6) 8. Be able to comply with protocol and exchange information effectively with the researchers, agree on the written informed consent to participate in the clinical trial
Exclusion criteria
Phase 1a: Subjects with at least 1 of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Concentration-Time Curve (AUC 0-336) | 0, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 336 hours |
| Percentage of Patients achieving Rapid Virological Response (RVR) | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects with incidence of adverse events | 15 days |
Countries
Vietnam
Outcome results
None listed