Sustained Virological Response (SVR)Rate of Pegasys Plus Ribavirin in Patients With Chronic Hepatitis C

NCT01639547 | Terminated

• 1 other identifier: CTC-133
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to evaluate the effect of PEGASYS® (peginterferon alfa-2a 40KD) plus Robatrol® (ribavirin) combination therapy given for 36 weeks versus 48 weeks on the clearance of HCV viremia 24 weeks after treatment end

Conditions

Chronic Hepatitis C

Keywords

PEGASYS® PLUS RIBAVIRIN

Outcome Measures

Primary Outcomes (1)

• Sustained virological response

  Sustained virological response (SVR) defined as percentage of patients with HCV RNA \< 15 IU/ML as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test at 24 weeks post completion of the 36 or 48 week treatment periods.

  At 24 weeks after end of treatment

Secondary Outcomes (3)

• Virological Response Rate at week 2

  At treatment week 2

• Virological response at end of treatment

  At end of treatment

• Correlation of virological response and SVR rate

  At 24 weeks after end of treatment

Study Arms (2)

PEGASYS® plus ROBATROL® for 36 weeks

EXPERIMENTAL

Drug: Peginterferon alfa-2a plus Ribavirin

PEGASYS® plus ROBATROL® for 48 weeks

ACTIVE COMPARATOR

Drug: Peginterferon alfa-2a plus Ribavirin

Interventions

Peginterferon alfa-2a plus Ribavirin DRUG

Peginterferon alfa-2a(pre-filled syringes 180 mcg/0.5 ml once a week) plus ribavirin(200 mg/Capsules, 1000\~1200 mg daily in split doses (morning/evening)) for 36 or 48 weeks

Also known as: PEGASYS® plus ROBATROL®

PEGASYS® plus ROBATROL® for 36 weeks; PEGASYS® plus ROBATROL® for 48 weeks

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~70 years old
• Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribarivin
• Chronic hepatitis C, genotype 1, HCV-RNA \> 0.8x106 IU/ml, achieving RVR (undetectable HCV RNA at week 4) in the SoC treatment
• Patient must be able to comply with the assessments during the study
• Compensated liver disease (Child-Pugh Grade A clinical classification for patients with cirrhosis: total score ≦ 6)
• All fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment with study drugs and 6 months post treatment completion

You may not qualify if:

• History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
• History or other evidence of decompensated liver disease
• Signs or symptoms of hepatocellular carcinoma
• Co-infection with hepatitis A, hepatitis B or human immunodeficiency virus (HIV)
• Not adequately controlled thyroid dysfunction, diabetes mellitus (HbA1c \>8.5%) or psychiatric disorders, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
• History of a severe seizure disorder or current anticonvulsant use
• History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
• Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration) or clinically relevant ophthalmological disorder (e.g. due to diabetes mellitus or hypertension)
• Women with on-going pregnancy or breast feeding
• Male partners of women who are pregnant
• Subjects with any of the following laboratory abnormalities
• Platelet count \< 90,000/mm3
• Absolute neutrophil count \< 1,500 /mm3
• Hemoglobin \< 12 g/dL (F), 13 g/dL (M)
• Creatinine \> ULN

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (7)

Show Chwan Memorial Hospital

Changhua, 500, Taiwan

Location

Changhua Christian Hospital

Changhua County, 500, Taiwan

Location

Keelung Chang Gung Memorial Hospital

Keelung, 222, Taiwan

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

Tungs' Taichung MetroHarbor Hospital

Taichung, 435, Taiwan

Location

Taipei Medical University - Shuang Ho Hospital

Taipei County, 235, Taiwan

Location

Linkou Medical Center, Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a; Ribavirin

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

Study Officials

• I-Shyan Sheen, M.D.

  Linkou Medical Center, Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 28, 2012
• First Posted: July 12, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 29, 2015

Record last verified: 2015-07

Locations

TW (7)