Individually Adapted Therapy Duration for the Treatment of Chronic Hepatitis C Genotype 1 Infection (NCT00351403) | Clinical Trial Compass
CompletedPhase 4
Individually Adapted Therapy Duration for the Treatment of Chronic Hepatitis C Genotype 1 Infection
Germany390 participantsStarted 2006-07
Plain-language summary
Patients with chronic hepatitis C genotype 1 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 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with a chronic HCV infection (HCV antibodies and HCV RNA positive)
* Presence of a HCV genotype 1 infection
* Presence of a compensated liver disease satisfying following hematological and biochemical minimum criteria: - Hemoglobin value \>= 13 g/dl in men, \>= 12 g/dl in women - Leukocytes \>= 3.000/mm3 or neutrophile granulocytes \> 1.500/mm3 - Thrombocytes \> 80.000/mm3
* Total bilirubin in the normal range
* Albumin in the normal range
* Serum creatinine in the normal range THS in the normal range
* Exclusion of an autoimmune hepatitis
* Alpha-Fetoprotein in the normal range
* Negative HIV test
* Negativity of Hepatitis B surface antigens (Hbs-Ag)
* Normal or elevated ALT/GTP values at screening
* At known diabetes mellitus or hypertension an ophthalmologic examination must be performed
* Liver biopsy within the last 12 months must confirm the diagnoses of a chronic hepatitis
* A confirmation must be given that sexually active patients practice a save method of contraception during the therapy and 6 (women) to 7 (men) months after the therapy
Exclusion Criteria:
* Age \< 18 years, \> 70 years
* Previous treatment of hepatitis c with (Peg)Interferon alfa or (Peg)Interferon alfa/Ribavirin
* Patients with organ transplantations other than cornea or hair
* Infection with HCV genotype 2,3,4,5 or 6
* Pregnant or nursing women
* Any other reason for the liver disease than chronic hepatitis C
* Suspected hypersensitivity to Interferon, Peginterfe…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sustained viral response (HCV RNA negativity 24 weeks after end of treatment)