Phase I/II Trial of KRN7000 in Patients With Chronic Hepatitis C Infection

This study has been completed.
Sponsor:
Collaborator:
Kyowa Hakko Kirin Company, Limited
Information provided by:
Foundation for Liver Research
ClinicalTrials.gov Identifier:
NCT00352235
First received: July 13, 2006
Last updated: NA
Last verified: July 2006
History: No changes posted
  Purpose

Phase I/II trial of KRN7000 in patients with chronic hepatitis C.

Study objectives: To evaluate and compare the safety and tolerability of 3 ascending doses of a-GalCer.

The primary efficacy parameter: HCV-RNA response at the end of treatment. Secondary efficacy parameter: Serum ALT response. Further objectives of the study are to evaluate the effect of a-GalCer on serum cytokines IFNg and TNFa and on iNKT cells.

Number of dose levels: 3 Investigational product: KRN7000 Route of administration: intravenous Dosages and frequency: 0.1, 1, 10 mcg/kg, monthly injection, 3 times (day 0, day 28 and day 56)


Condition Intervention Phase
Chronic Hepatitis C
Drug: KRN7000
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase I/II Trial of KRN7000 in Patients With Chronic Hepatitis C Infection

Resource links provided by NLM:


Further study details as provided by Foundation for Liver Research:

Primary Outcome Measures:
  • Decrease in serum hepatitis C virus ribonucleic acid (HCV RNA) levels.

Secondary Outcome Measures:
  • Normalization of serum ALT levels.
  • Effect on serum cytokines IFNg and TNFa and on iNKT cells.

Estimated Enrollment: 36
Study Start Date: August 2003
Estimated Study Completion Date: May 2005
Detailed Description:

Phase I/II trial of KRN7000 in patients with chronic hepatitis C.

This study is a multicenter double-blind randomized placebo-controlled phase I/II dose-escalation trial. The protocol is conducted in The Netherlands, Belgium and Germany. Patients with chronic hepatitis C who met the inclusion criteria are assigned to receive a-GalCer (KRN7000 ((2S, 3S, 4R)-1-O-(a-D-galactopyranosyl)-N-hexacosanoyl-2-amino-1,3,4-octadecanetriol), Kirin Pharmaceutical Co., Ltd., Gunma, Japan) or placebo intravenously, thrice with intervals of 4 weeks. Cohorts of 12 patients are entered at each of the three dose levels (0.1, 1 and 10 mg/kg body weight). Three patients per dose level are randomized to the placebo arm.

Dose escalation to the next cohort are decided after evaluation by a safety review board of all the safety data collected on all the patients who had completed 3 weeks after the first injection in the preceding dose cohort. After completion of 8 weeks of treatment, with injections at 0, 4 and 8 weeks, patients are monitored without further therapy for an additional 16 weeks.

Study objectives: The objective of the study is to evaluate and compare the safety and tolerability of 3 ascending doses of a-GalCer. The primary efficacy parameter is the response at the end of treatment, based on serum hepatitis C virus ribonucleic acid (HCV RNA) levels. As a secondary efficacy parameter serum ALT levels are evaluated. Further objectives of the study are to evaluate the effect of a-GalCer on serum cytokines IFNg and TNFa and on iNKT cells.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Chronic hepatitis C Liver biopsy within 3 years of entry into the study HCV RNA > 10000 copies/mL Age 18-70 years ALT > 1.2 times ULN written informed consent Adequate contraception

Exclusion Criteria:

Cirrhosis Decompensated liver disease ALT > 10 times ULN Pregnancy Major other illness

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00352235

Locations
Netherlands
Erasmus MC
Rotterdam, Netherlands, 3000CA
Sponsors and Collaborators
Foundation for Liver Research
Kyowa Hakko Kirin Company, Limited
Investigators
Principal Investigator: Carin MJ van Nieuwkerk, MD, PhD VU medical Center, Amsterdam
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00352235     History of Changes
Other Study ID Numbers: KRN7000 HCV
Study First Received: July 13, 2006
Last Updated: July 13, 2006
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Foundation for Liver Research:
Chronic hepatitis C
KRN7000
a-GalCer
immunotherapy
Natural Killer T cells
interferon

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
KRN 7000
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014