Status:
COMPLETED
Chronic Hepatitis C Non-Responder Study With AdoMet and Betaine
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
50-60% of patients with chronic hepatitis C are not cured by treatment with pegylated IFNα plus ribavirin. Retreatment of non-responders of previous (pegylated) IFNα plus ribavirin therapies with peg...
Eligibility Criteria
Inclusion
- Male and female between 18 and 65 years.
- Non-responders in previous treatments with IFNα plus ribavirin or pegylated IFNα plus ribavirin.
- Elevated ALT-levels on at least two occasions during \>6 months preceding entry.
- Detection of HCV RNA in serum (PCR).
- Compensated liver disease (Child-Pugh A) and a Child-Pugh score \<5.
- The following minimal hematologic and biochemical criteria:
- Hemoglobin for males and females \>11g/dl
- Absolute Neutrophil count \>1500 cells/mm3
- Platelets \>75'000/mm3
- HBs Ag negative.
- ANA \<1:320, and no evidence for autoimmune hepatitis.
- α-Fetoprotein \<50μg/l (when between upper limit of normal and 50μg/l, ultrasonographical exclusion of hepatocellular carcinoma (HCC) is needed).
- Fasting blood glucose within normal limits, if history of diabetes or hypertension, a pre-therapy ocular examination is indicated.
- TSH within normal limits or adequately controlled.
- Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 2-3 week period prior to the first dose of study drug. Additionally, all fertile males and females must be using effective contraception during treatment and during the 6 months after treatment end. This may include, but is not limited to, using birth control pills, IUDs, condoms, diaphragms, or implants, being surgically sterilized, or being in a post-menopausal state.
- Willingness to give written informed consent and willingness to participate to and comply with the study
Exclusion
- Women with ongoing pregnancy or breast feeding.
- Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBe Ag.
- Positive test at screening for HIV.
- History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures).
- Hypersensitivity to study drugs.
- Participation in any other clinical trial within 30 days of entry into this protocol.
- Treatment with any investigational drug within 30 days of entry into this protocol.
- History or evidence of decompensated liver disease (Child-Pugh B/C) and a Child-Pugh score \>5. Ascites, coagulopathy, hyperbilirubinemia, hepatic encephalopathy, or hypoalbuminemia and a Child-Pugh score \>5 are conditions consistent with decompensated liver disease.
- History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease.
- Hepatocellular carcinoma (HCC) or α-Fetoprotein \>50μg/l.
- Patients with organ transplants other than cornea and hair transplant.
- Therapy with any antisystemic or immunomodulatory treatment (including supra-physiologic doses of steroids or radiation) \<6 months prior the first dose of study drug
- Hemoglobinopathy (e.g. thalassemia) or any other cause of or tendency for hemolysis.
- Any known preexisting medical condition that could interfere with the patient's participation in and completion of the study such as:
- Preexisting psychiatric condition, especially depression, or a history of severe psychiatric disorder, such as major psychosis, suicidal ideation and/or suicidal attempts (based on a mandatory psychiatric advice).
- CNS trauma or active seizure disorders requiring medication.
- Significant cardiovascular dysfunction.
- Poorly controlled diabetes mellitus.
- Renal dysfunction, i.e. serum creatinine levels \>1.5 times upper limit of normal.
- Autoimmune diseases.
- Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration).
- Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids.
- Clinical gout.
- Important substance abuse (alcohol \>80 g/d, i.v. drugs etc.).
- Active opportunistic infections.
- Non-Hodgkin lymphoma or Hodgkin lymphoma.
- Kaposi sarcoma.
- Inability or unwillingness to provide informed consent or abide by the requirements of the study.
- Male partners of pregnant women.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00310336
Start Date
August 1 2006
End Date
September 1 2009
Last Update
October 28 2010
Active Locations (1)
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1
University Hospital Basel
Basel, Canton of Basel-City, Switzerland, 4031