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 range18 Years – 70 Years
SexALL
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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…
What they're measuring
1
Sustained viral response (HCV RNA negativity 24 weeks after end of treatment)