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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2011 results in: https://www.ncbi.nlm.nih.gov/pubmed/21784046