Please assess the completion status of the following clinical trial:

Trial Title: Pilot Study of Betaine + Combination Antiviral Therapy for Chronic Hepatitis C Genotype 1 Non-responder/Relapsers

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: EARLY_PHASE1
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* 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 Criteria:~* 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

- Gender: ALL
- Minimum Age: 19 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Safety & Efficacy of Betaine Combined with Standard Anti-viral Therapy (Type: EXPERIMENTAL): The primary objective is to examine safety \& efficacy of betaine when combined with standard anti-viral therapy in previously treated adult subjects with chronic hepatitis C infected with genotype 1. Efficacy will be determined through comparison of the sustained viral response (SVR) to our protocol three-drug regimen (Betaine, Peginterferon plus Ribavirin) to that historically seen in relapsers and non-responders when retreated with standard therapy (Peginterferon and Ribavirin alone).~Betaine (trimethylglycine) dose is 10 gm twice a day for 48 weeks. Pegasys (peginterferon alpha 2a) dose is 180mcg/0.5 ml subcutaneous injection for 48 weeks. Coegus (ribavirin) dose is 200mg - weight based, 1000 - 1200 mg/day for body weight or 75mg in 2 divided doses.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: terminate
termination_type: lack of efficacy