Condition category
Infections and Infestations
Date applied
09/08/2006
Date assigned
04/09/2006
Last edited
04/09/2006
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 Christoph Sarrazin

ORCID ID

Contact details

Saarland University Hospital
Internal Medicine II – Gastroenterology
Hepatology
Endocrinology
Diabetology and Dietary Medicine
Gebäude 41
Kirrberger Straße
Homburg/Saar
66421
Germany
+49 (0) 6841 16 23203
incsar@uniklinik-saarland.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00351403

Protocol/serial number

P04755

Study information

Scientific title

Acronym

INDIV-2

Study hypothesis

Patients with chronic hepatitis C genotype one virus infection are usually treated with interferon alfa plus ribavirin over 48 weeks. For some patients this might be too long, for others too short. An individually adapted therapy length from 24 to 72 weeks will be determined in dependence of the initial virus load and the time to Hepatitis C Virus RiboNucleic Acid (HCV RNA) negativity.

The primary objective is to compare the cumulative rate of the Sustained Viral Response (SVR) of the patients with the individually adapted therapy duration to the SVR rates of a historic patient collective under the 48 week standard therapy.

Other objectives include:
1. To record the tolerance of the therapy with peginterferon alfa-2b plus ribavirin over 72 weeks inclusive the adverse reactions and the withdrawal rates.
2. To evaluate the biochemical response to the treatment (Alanine Aminotransferase [ALT] values during and after the therapy) in comparison to the virological response to the treatment.
3. To evaluate the validity of the withdrawal rules of this trial at week 12 and 24 in comparison to the two-log-rule and a qualitative detection of the HCV RNA at week 24 with a detection limit of 50 IU/ml.
4. To evaluate the impact of the HCV RNA concentration before the therapy, and the HCV kinetic during the therapy on the response to the treatment in the different groups.
5. To evaluate the impact of the serum concentration of ribavirin on anaemia and the virological therapy response, as well as the dependence of the serum concentration of ribavirin on the creatinine clearance in comparison to the body weight.

Ethics approval

Ethics commission of the physician chamber of the Saarland approved on 31st May 2006 (reference number: 56/06).

Study design

Non-randomised, open label, historical control, parallel assignment, safety/efficacy study.

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Chronic hepatitis C genotype one infection

Intervention

Adapted therapy duration from 24 to 72 with peginterferon alfa-2b plus ribavirin.

Intervention type

Drug

Phase

Not Specified

Drug names

Peginterferon alfa-2b and ribavirin

Primary outcome measures

Sustained viral response (HCV RNA negativity 24 weeks after end of treatment).

Secondary outcome measures

1. Percentage of patients with a normal GPT level 24 weeks after end of treatment (sustained biochemical response rate)
2. Percentage of patients with HCV RNA negativity at the end of the therapy (virological end of treatment response rate)
3. Percentage of patients with a normal GPT level at the end of the therapy (biochemical end of treatment response rate)
4. Explorative examination of pretherapeutic parameters

Overall trial start date

15/07/2006

Overall trial end date

15/06/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with a chronic HCV infection (HCV antibodies and HCV RNA positive)
2. Presence of a HCV genotype one infection
3. Presence of a compensated liver disease satisfying following hematological and biochemical minimum criteria:
a. Haemoglobin value more than or equal to 13 g/dl in men, more than or equal to 12 g/dl in women
b. Leukocytes more than or equal to 3.000/mm^3 or neutrophil granulocytes more than 1.500/mm^3
c. Thrombocytes more than 80.000/mm^3
4. Total bilirubin in the normal range
5. Albumin in the normal range
6. Serum creatinine in the normal range
7. Thyroid Stimulating Hormone (TSH) in the normal range
8. Exclusion of an autoimmune hepatitis
9. Alpha-Fetoprotein in the normal range
10. Negative Human Immunodeficiency Virus (HIV) test
11. Negativity of Hepatitis B surface antigens (HBsAg)
12. Normal or elevated ALT/Glutamic Pyruvic Transaminase (GPT) values at screening
13. At known diabetes mellitus or hypertension an ophthalmologic examination must be performed
14. Liver biopsy within the last 12 months must confirm the diagnoses of a chronic hepatitis
15. A confirmation must be given that sexually active patients practice a save method of contraception during the therapy and six (women) to seven (men) months after the therapy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

390

Participant exclusion criteria

1. Aged under 18 years, or over 70 years
2. Previous treatment of hepatitis C with (peg)interferon alfa or (peg)interferon alfa/ribavirin
3. Patients with organ transplantations other than cornea or hair
4. Infection with HCV genotype two, three, four, five or six
5. Pregnant or nursing women
6. Any other reason for the liver disease than chronic hepatitis C
7. Suspected hypersensitivity to interferon, peginterferon or ribavirin
8. Participation in a clinical trial or treatment with an investigational product 30 days before inclusion in this study
9. Patients with any kind of hemoglobinopathy
10. Documented liver disease in advanced state liver cirrhosis (Child-Pugh classes B and C)
11. Such known and existing clinical conditions that might challenge the participation or completion of this clinical trial such as depressions, psychosis, severe psychiatric diseases, suicide ideations, Central Nervous System (CNS) traumata or cramps which need medicamentous treatment
12. Relevant cardiovascular dysfunctions in the last six months or patients with clinically relevant changes in their Electrocardiogram (ECG)
13. Insufficiently adjusted diabetes mellitus
14. Severe chronic lung diseases (as e.g. Chronic Obstructive Pulmonary Disease [COPD])
15. Immunologic diseases or autoimmune diseases or any other disease which demands a long-time treatment with corticosteroids during this clinical trial
16. Clinically relevant gout
17. Abuse of drugs, alcohol or pharmaceuticals
18. Patient with clinically relevant changes of the retina
19. Missing ability or willingness to understand the purpose of this study or to give a written consent for participating in this study

Recruitment start date

15/07/2006

Recruitment end date

15/06/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Saarland University Hospital
Homburg/Saar
66421
Germany

Sponsor information

Organisation

Saarland University Hospital (Universitätsklinikum des Saarlandes) (Germany)

Sponsor details

c/o Dr Christoph Sarrazin
Internal Medicine II – Gastroenterology
Hepatology
Endocrinology
Diabetology and Dietary Medicine
Gebäude 41
Kirrberger Straße
Homburg/Saar
66421
Germany
+49 (0) 6841 16 23203
incsar@uniklinik-saarland.de

Sponsor type

University/education

Website

http://www.uniklinikum-saarland.de/en

Funders

Funder type

University/education

Funder name

Saarland University Hospital (Universitätsklinikum des Saarlandes) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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