Condition category
Infections and Infestations
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
03/04/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Huub Gelderblom

ORCID ID

Contact details

Academic Medical Center (AMC)
Department of Gastroenterology
AMC Liver Center
C2-331
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5668748
h.c.gelderblom@amc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

VKF2

Study hypothesis

In this study are patients with chronic hepatitis C with a previous virological relapse or a virological non response to IFN or IFN/Ribavirin combination therapy, with a high induction dose of pegylated Interferon combined with Ribavirin and Amantadine. Subsequently a lower dose pegylated Interferon combined with Ribavirin and Amantadine is given to the patients. The aim of the study is to determine if a drop in viral load in the first 4 weeks of treatment is predictive for virological sustained response.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Hepatitis C

Intervention

This study will be an open pilot study. Data will be analysed on an intention to treat basis.
Eighty patients will be included.
All patients:
2 weeks Intron A (3 x 6 MU daily), Ribavirin (1000-1200 mg daily) and Amantadine (200 mg daily), 2 weeks Intron A (3 x 3 MU daily), Ribavirin (1000-1200 mg daily) and Amantadine (200 mg daily), 2 weeks Intron A (2 x 3 MU daily), Ribavirin (1000-1200 mg daily) and Amantadine (200 mg daily).
After 6 weeks of induction therapy, 3 groups of patients will be divided according to their viral load decline.
Viral load decline calculated by the equation:
Viral load decline = Viral load at day 0 – Viral load at week 4
Viral load expressed in log.

Group 1, non responders: =/< 0.5 log decline in viral load
Group 2, slow responders: >0.5 - <3 log decline in viral load
Group 3, rapid responders: >/= 3 log decline in viral load

Non-responders (group 1) and slow responders (group 2):
42 weeks: Pegylated Interferon 1.5 microgram/kg/week, Ribavirin 1000-1200 mg a day, Amantadine 200 mg a day.
Treatment will be stopped at week 28 when patients are still HCV-RNA positive at week 24 of treatment.

Rapid responders (group 3):
Patients will be randomised to receive either:
Group 3A: 22 weeks treatment: Pegylated Interferon 1.5 microgram/kg/week, Ribavirin 1000-1200 mg a day, Amantadine 200 mg a day
OR
Group 3B: 42 weeks treatment: Pegylated Interferon 1.5 microgram/kg/week, Ribavirin 1000-1200 mg a day, Amantadine 200 mg a day
Treatment will be stopped at week 28 in all patients who are HCV-RNA positive at week 24 of treatment.

Intervention type

Drug

Phase

Not Specified

Drug names

pegylated interferon, ribavirin and amantadine.

Primary outcome measures

To determine if initial drop in viral load is predictive for virological sustained response.

Secondary outcome measures

To determine if other co-factors i.e. viral load or HCV genotype are predictive for sustained virological response.

Overall trial start date

01/01/2002

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with a chronic hepatitis C virus (HCV) infection, with virological relapse, or with virological non response to previous antiviral therapy diagnosed by
a. Anti-HCV positive
b. Serum HCV-RNA positive by polymerase chain reaction (PCR)
2. Patients who have not used antiviral or immune modulating therapy, including interferon, in the previous 6 months
3. Male and female patients >18 and <65 years of age
4. Patients who have given written informed consent after a detailed explanation of the study by the investigator

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

61

Participant exclusion criteria

1. Patients who are pregnant and patients (male or female) who are not willing to practise adequate contraception during the treatment period and up to 6 months after ending the treatment period
2. Patients who are HBsAg or HIV antibody positive or are unwilling to have these tests done
3. Patients with decompensated cirrhosis (e.g. albumin <32 g/l, PTT prolonged >4 s, bilirubin > upper limit of normal, AT III <60%, ascites, gastrointestinal [GI] bleeding, encephalopathy)
4. Patients with a history of intravenous (iv) drug use within 6 months prior to entry
5. Patients with any clinically significant systemic disease other than liver disease (e.g. malignant disease, congestive heart failure, uncontrolled diabetes mellitus, renal failure [serum creatinine >181 micromol/ml], or autoimmmune disease)
6. Patients with a history of auto-immune hepatitis
7. Patients using immune modulating treatment during the 6 months prior to study entry
8. Patients with a history of hypersensitivity to any component of the study drugs
9. Patients with pre-existing bone marrow depression such as hematocrit <32%, white blood cell count <3.0 x 10^9/l, granulocytes <10%, platelets <100 x 10^9/l, neutrophil count <1.5 x 10^9 or Hemoglobin <8.1 mmol/l for males and <7.5 mmol/l for females
10. Patients with severe depression or other psychiatric illness
11. Patients with a history of epilepsy, or other clinically significant central nervous system (CNS) dysfunction
12. Patients with any condition, that in the opinion of the investigator, might interfere with the outcome of the study

Recruitment start date

01/01/2002

Recruitment end date

01/01/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Center (AMC), Department of Gastroenterology, AMC Liver Center (The Netherlands)

Sponsor details

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Not defined

Website

Funders

Funder type

Industry

Funder name

Schering-Plough

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes