Pilot Comparison of Standard Antiviral Therapy With and Without 12 Weeks of Betaine in Genotype 1 Naive Patients

NCT00571714 | Withdrawn DMC

• 1 other identifier: 0159-07-FB
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary purpose of the study is to compare the safety and effectiveness of standard treatment for chronic hepatitis C using peginterferon alpha-2a (Pegasys) and ribavirin (Copegus) to those same medications plus a dietary supplement called betaine when added for the first 12 weeks of treatment. Peginterferon alpha-2a (Pegasys) and ribavirin (Copegus) are approved by the FDA (Food and Drug Administration) for the treatment of chronic hepatitis C. Betaine is a dietary supplement and occurs naturally in the body. It is not a medication regulated by the FDA or an approved drug for chronic hepatitis C.

Conditions

Chronic Hepatitis C

Keywords

Chronic hepatitis C; Pilot Comparison; Peginterferon alph-2a; Ribavirin; Betaine; Genotype 1; Treatment naive

Outcome Measures

Primary Outcomes (1)

• Sustained Viral Response 24 weeks following the end of anti-viral therapy

  no patients enrolled

  72 weeks

Secondary Outcomes (4)

• Comparison of rapid and early virologic response in the first 4 and 12 weeks of therapy

  12 weeks

• Comparison of the safety of the two treatment regimens

  48 weeks

• Comparison of ALT normalization between the two regimens

  48 weeks

• Comparison of the effect on interferon gene signaling in peripheral blood mononuclear cells between the two regimens in the first 12 weeks of therapy.

  12 weeks

Study Arms (2)

1 Standard Peginterferon alpha-2a plus Rivavirin Therapy

ACTIVE COMPARATOR

Peginterferon alpha-2a once a week plus weight based ribavirin (800-1400mg/day)in 2 divided daily doses

Drug: Peginterferon alpha-2a and ribavirin

2 Peginterferon alpha-2a plus Rivavirin Therapy with Betaine for First 12 Weeks

ACTIVE COMPARATOR

Peginterferon alpha-2a once a week plus weight based ribavirin (800-1400mg/day) in 2 divided daily doses plus betaine (20gm/day) in 2 divided doses for 12 weeks followed by Peginterferon alpha-2a q week plus weight based ribavirin (800-1400mg/day) in 2 divided daily doses for 36 weeks

Drug: Peginterferon alpha-2a , ribavirin and betaine

Interventions

Peginterferon alpha-2a and ribavirin DRUG

Peginterferon alpha-2a 180mcg by subcutaneous injection every week and weight based ribavirin, 800 to 1400mg/day by mouth in two divided doses every day for 48 weeks

Also known as: Pegasys, Copegus

1 Standard Peginterferon alpha-2a plus Rivavirin Therapy

Peginterferon alpha-2a , ribavirin and betaine DRUG

Peginterferon alpha-2a 180mcg given by subcutaneous injection every week plus weight based ribavirin 800 to 1400 mg/day by mouth in divided doses twice a day plus betaine 10 gm dissolved in juice twice a day for twelve weeks followed by peginterferon alpha-2a 180 mcg given by subcutaneous injection every week plus weight based ribavirin 800 to 1400mg/day by mouth in divided doses twice a day for 36 weeks.

Also known as: Pegasys, Copegas

2 Peginterferon alpha-2a plus Rivavirin Therapy with Betaine for First 12 Weeks

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be willing to give informed consent and be able to adhere to dose and visit schedules.
• History of chronic hepatitis C as documented by either anti-HCV or HCV RNA positivity.
• Adult subjects 19-70 years of age, of either gender
• Liver biopsy within 3 years prior to the screening 1 visit.
• 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.

You may not qualify if:

• 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.
• History of new hepatitis C exposure within the last 6 months
• Prior treatment for chronic hepatitis C.
• 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
• Treatment with any investigational drug within 30 days of Screening visit 1.
• Any other cause for liver disease other than CHC.
• Coagulopathies including hemophilia
• Hemoglobinopathies
• G6PD deficiency
• 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

Sponsors & Collaborators

• University of Nebraska: lead

Related Publications (3)

• Abdelmalek MF, Angulo P, Jorgensen RA, Sylvestre PB, Lindor KD. Betaine, a promising new agent for patients with nonalcoholic steatohepatitis: results of a pilot study. Am J Gastroenterol. 2001 Sep;96(9):2711-7. doi: 10.1111/j.1572-0241.2001.04129.x.

  PMID: 11569700 BACKGROUND

• Duong FH, Christen V, Filipowicz M, Heim MH. S-Adenosylmethionine and betaine correct hepatitis C virus induced inhibition of interferon signaling in vitro. Hepatology. 2006 Apr;43(4):796-806. doi: 10.1002/hep.21116.

  PMID: 16557551 BACKGROUND

• 8. Mukherjee S, Bernard T, Schafer D, et al. Impact of betaine on hepatic fibrosis and homocysteine in nonalcoholic steatohepatitis: a prospective cohort study [abstract]. Hepatology 2005; 42: 610A.

  RESULT

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Ribavirin; peginterferon alfa-2a; Betaine

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• Mark E Mailliard, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: December 12, 2007
• Study Start: April 1, 2008
• Primary Completion: March 4, 2010
• Study Completion: March 4, 2010
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share