Phase I/II Trial of KRN7000 in Patients With Chronic Hepatitis C Infection
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00352235 |
Recruitment Status
:
Completed
First Posted
: July 14, 2006
Last Update Posted
: July 14, 2006
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 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 |
- Decrease in serum hepatitis C virus ribonucleic acid (HCV RNA) levels.
- Normalization of serum ALT levels.
- Effect on serum cytokines IFNg and TNFa and on iNKT cells.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Netherlands | |
Erasmus MC | |
Rotterdam, Netherlands, 3000CA |
Principal Investigator: | Carin MJ van Nieuwkerk, MD, PhD | VU medical Center, Amsterdam |
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 |