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

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ClinicalTrials.gov Identifier: NCT00352235
Recruitment Status : Completed
First Posted : July 14, 2006
Last Update Posted : July 14, 2006
Sponsor:
Collaborator:
Kyowa Hakko Kirin Co., Ltd
Information provided by:
Foundation for Liver Research

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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 or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: KRN7000 Phase 1 Phase 2

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase I/II Trial of KRN7000 in Patients With Chronic Hepatitis C Infection
Study Start Date : August 2003
Study Completion Date : May 2005

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U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00352235


Locations
Netherlands
Erasmus MC
Rotterdam, Netherlands, 3000CA
Sponsors and Collaborators
Foundation for Liver Research
Kyowa Hakko Kirin Co., Ltd
Investigators
Principal Investigator: Carin MJ van Nieuwkerk, MD, PhD VU medical Center, Amsterdam
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00352235     History of Changes
Other Study ID Numbers: KRN7000 HCV
First Posted: July 14, 2006    Key Record Dates
Last Update Posted: July 14, 2006
Last Verified: July 2006

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 C
Hepatitis, Chronic
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
Antineoplastic Agents