The Study of Safety, Pharmacokinetics, Pharmacodynamics of Peglamda (Peginterferon Lamda 1) on Healthy Volunteers and the Preliminary Evaluation of Peglamda and Hepasig (Ribavirin) Treatment's Effects on Chronic Hepatitis C Patients

NCT02063607 | Completed Phase 1

• 1 other identifier: NNG01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Keywords

Hepatitis C naive

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Number of subjects with incidence of adverse events

  15 days

Study Arms (2)

Peginterferon alfa 2a

ACTIVE COMPARATOR

Peginterferon alfa 2a 180 mcg

Biological: Peginterferon lambda

Peginterferon Lambda

EXPERIMENTAL

Peginterferon Lambda 60,120,180 and 240 mcg

Biological: Peginterferon lambda

Interventions

Peginterferon lambda BIOLOGICAL

Peginterferon Lambda; Peginterferon alfa 2a

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteers (male and female) between the ages of 18-45
• Women have a negative pregnancy test result at the time of study.
• Clinical examination and result laboratory for 7 days before starting the trial must be inside the normal range.
• Currently not following any treatment regimen (except for using the oral contraceptive).
• Body mass index is between the range and / or not 25% difference compared to the normal BMI (Appendix 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
• Patients with chronic hepatitis C (male and female).
• Ages between 18 - 65 years old.
• 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.
• No previous treatment with IFN or IFN treatment with rapid viral response or already have completely viral response but leave the treatment early.
• HCV-RNA levels in serum \> 80 IU / mL.
• The haematological and biochemical (except ALT / AST) parameters must be within normal limits.
• Body weight in the normal range of 25% difference compared to the normal BMI (Appendix 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

You may not qualify if:

• With a history of drug abuse, alcohol or drug using within 1 year before taking part in the clinical trial. AUDIT-C scale (WHO) will be used to assess the use of alcohol. The score ≥ 4 in men or ≥ 3 in women are considered as alcoholics.
• History of depression
• History of chronic diseases related to the respiratory system, cardiovascular, gastrointestinal, malignant disease affecting to the function of the organ systems. Having any interferon or antiviral therapy within 4 months before the trial
• Participate in any clinical trial within 3 months prior the testing
• Use of any drug in the last period of relatively positive test which last approximately 6 times the half-life of the drug.
• Blood donor with more than 400 mL of blood within 3 months prior the testing
• Influenza infection or cold symptoms within 2 weeks before the trial
• Having positive tests of HBV, HCV or HIV
• Breastfeeding women
• Co-infection with hepatitis B and/or HIV.
• Hepatic Impairment
• Cirrhosis
• Positive tests with antibody of Peginterferon lambda 1 and Peginterferon alpha 2a.
• History of chronic diseases related to the respiratory system, cardiovascular, gastrointestinal, malignant disease affecting to the function of the organ systems.
• A history of immune disorders (eg, inflammatory bowel disease, hemorrhagic thrombocythemia, lupus erythematosus, autoimmune hemolytic anemia, autoimmune disease, scleroderma, severe psoriasis, arthritis rheumatoid ...)

Sponsors & Collaborators

• Nanogen Pharmaceutical Biotechnology Joint Stock Company: lead

Study Sites (1)

The Military 108 Hospital

Hanoi, 10000, Vietnam

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

peginterferon lambda-1a

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Dr.Chinh Trong Nguyen, PhD

  The Military 108 Hospital

  PRINCIPAL INVESTIGATOR

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: February 11, 2014
• First Posted: February 14, 2014
• Study Start: December 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: July 1, 2016
• Last Updated: December 15, 2016

Record last verified: 2014-02

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)