Status:
TERMINATED
Pilot Study of Betaine + Combination Antiviral Therapy for Chronic Hepatitis C Genotype 1 Non-responder/Relapsers
Lead Sponsor:
University of Nebraska
Conditions:
Chronic Hepatitis C
Genotype 1
Eligibility:
All Genders
19+ years
Phase:
EARLY_PHASE1
Brief Summary
This is a non-randomized, open-label study examining the safety and efficacy of betaine in addition to standard anti-viral therapy in genotype 1 hepatitis C non-responders or relapsers to previous peg...
Detailed Description
The primary objective is to examine the safety and efficacy of the betaine when combined with standard anti-viral therapy in previously treated adult subjects with chronic hepatitis C infected with ge...
Eligibility Criteria
Inclusion
- Subject must be willing to give informed consent and be able to adhere to dose and visit schedules.
- History of chronic hepatitis C, genotype 1, non-responders or relapsers as documented by genotype testing and HCV RNA levels at 12 weeks ( \< 2 log change) during therapy or at 3 - 12 months post therapy, respectively.
- Adult subjects 18-70 years of age, of either gender
- Liver biopsy within 3 years prior to the screening 1 visit with a pathology report confirming that the histological diagnosis is consistent with chronic hepatitis C.
- Compensated liver disease with the following maximum hematologic, biochemical and serologic criteria at the Screening visit (WNL=within normal limits) Hemoglobin \> 12 g/dl for females and \>13 g/dl for males, WBC \> 3000/mm3, Platelets \> 80,000/mm3, Direct Bilirubin - WNL. Indirect bilirubin - WNL, Albumin - WNL, Serum Creatinine - WNL.
- Fasting glucose should be 70 -140 mg/dl, results between 116-140 require a HbA1c \< 8.5%
- TSH - WNL
- Subjects with a history of mild depression may be considered for entry in to this study provided that a pretreatment assessment of the subject's affective status supports that the subject is clinically stable.
- Subjects with a history of substance abuse must have abstained from using the substance for at least one year prior to the Screening visit.
- Antinuclear antibodies (ANA) \< 1:320
- No radiologic evidence of a focal mass suggestive of hepatoma and/or ascites.
Exclusion
- Pregnant or nursing subjects. Subjects who intend to become pregnant during the study period. Subjects with partners who intend to become pregnant during the study period.
- Prior response to therapy and failure to achieve SVR which may have been due to treatment non-compliance, in the assessment of the investigator based upon subject's medical history.
- Participation in any clinical trial of a HCV protease inhibitor of any duration. Subjects may have received other investigational agents for the treatment of HCV, as long as they have also received an adequate course of Peg-IFN/RBV \[i.e., the investigational agent could not have replaced either Peg-IFN (such as Albuferon) or RBV (viramidine)\].
- History of new hepatitis C exposure within the last 6 months
- Current or intended use of G-CSF and/or GM-CSF during the stud period is prohibited. Current use of erythropoietin (EPO) is prohibited.
- Suspected hypersensitivity to any interferon product or ribavirin
- Participation in any other clinical trial within 30 days of Screening visit 1
- Treatment with any investigational drug within 30 days of Screening visit 1.
- Any other cause for liver disease other than CHC, including but not limited to: hemachromatosis, Alpha-1 antitrypsin deficiency, Wilson's disease, Autoimmune hepatitis, Alcoholic liver disease, Non-alcoholic steatohepatitis (NASH), Drug-related liver disease
- Known coagulopathies including hemophilia
- Known hemoglobinopathies
- Known G6PD deficiency
- Known coinfection with HIV and/or HBV
- Evidence of active or suspected malignancy or a history of malignancy within the last five years (with the exception of adequately treated basal cell carcinoma of the skin).
- Evidence of decompensated liver disease such as history or presence of ascites, bleeding varices or hepatic encephalopathy
- Subjects with organ transplants other than cornea or hair transplant
- Any Known preexisting medical condition, that could interfere with the subject's participation in and completion of the study including, but not limited to moderate to severe depression, or a history of severe psychiatric disorder, such as psychosis, suicidal ideation and/or suicidal attempt; Subjects with a past history or current use of lithium and/or antipsychotic drugs; CNS trauma or seizure disorder; Clinically significant ECG abnormalities and/or significant cardiovascular dysfunction within the past 2 years prior to Screening ; Poorly controlled diabetes mellitis; Chronic pulmonary disease (COPD); Immunologically mediated disease such as inflammatory bowel disease, rheumatoid arthritis, idiopathic thrombocytopenia purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis or symptomatic thyroid disorder; Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids: History of, or active clinical gout.
- Substance abuse, such as alcohol (\>80 g/day), IV drugs and inhaled drugs. Subjects with a history of substance abuse must have abstained from the abuse substance for at least one year. Subjects with clinically significant retinal abnormalities
- Any other condition which in the opinion of the investigator would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the protocol
- Subjects who are part of the staff personnel directly involved with the study
- Subjects who are immediate family members of the investigational study staff
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 12 2011
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00882193
Start Date
May 1 2009
End Date
January 12 2011
Last Update
November 30 2023
Active Locations (1)
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1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198