CClinicalTrials.gg
TerminatedNCT01639547Updated Jul 29, 2015

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

An interventional study of Peginterferon alfa-2a plus Ribavirin in Chronic Hepatitis C, sponsored by Chang Gung Memorial Hospital. Terminated at 7 sites in Taiwan. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-07-29.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Supportive care

Why this study was terminated
early termination due to difficult collection of patients
Phase
Not applicable
Study type
Interventional
Enrollment
410
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study 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

Read the detailed description

Pegylated interferon plus ribavirin brings a good therapeutic response and curability. However, the adverse effects and sufferings are lots. Response-guided, personalized treatment is current principle. In patients of CHC, GT1 PR treatment for 24 weeks is established in rapid virologic responders (RVR) who have low viral load before treatment. As to patients with RVR but high viral load (HVL), the treatment duration is 48 weeks that is the same as patients with complete early virologic response (cEVR). Is a shorter duration of treatment feasible for those with a good virokinetic response? The ideal treatment duration for patients of chronic hepatitis C, GT-1, high viral load with RVR has had no enough data yet. Is it really necessary to double the treatment duration (48 weeks) for patients of chronic hepatitis C, GT-1, high viral load with RVR? Is 36-week adequate for them? A multicenter trial of INDIV-2 was presented at EASL 2010. They treated CHC patients of naïve GT1 HVL and RVR for 30 weeks and got similarly good SVR as those treated for 48 weeks (85% vs. 82%).

Therefore, investigators design a randomized controlled study to investigate the SVR rates between treatment for 36 weeks and for 48 weeks in patients of CHC, GT1, HVL and RVR.

02

Conditions studied

  • Chronic Hepatitis C

Keywords

  • PEGASYS® PLUS RIBAVIRIN
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's planned enrollment of 410 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 20\~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

Exclusion criteria

Exclusion Criteria:

  • 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
    • ALT and/or AST > 10X ULN
    • Total serum bilirubin > 1.5 x ULN
  • Inability or unwillingness to provide written informed consent or abide by the requirements of the study
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
410 participants (estimated)

Study arms

  • Experimental
    PEGASYS® plus ROBATROL® for 36 weeks

    Drug: Peginterferon alfa-2a plus Ribavirin

  • Active comparator
    PEGASYS® plus ROBATROL® for 48 weeks

    Drug: Peginterferon alfa-2a plus Ribavirin

Interventions

  • DrugPeginterferon alfa-2a plus Ribavirin

    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®

06

What researchers measure

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.

    Time frame: At 24 weeks after end of treatment

Secondary outcomes

  1. Virological Response Rate at week 2

    Virological Response Rate at week 2 defined as the percentage of patients with HCV RNA \< 15 IU/ML as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV at 2 weeks post treatment.

    Time frame: At treatment week 2

  2. Virological response at end of treatment

    Virological response at end of treatment defined as the percentage of patients with HCV RNA \< 15 IU/ML as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test after the last dose of study medication(± 28 days).

    Time frame: At end of treatment

  3. Correlation of virological response and SVR rate

    Correlation of virological response (HCV RNA \< 15 IU/ML) at week 2 and SVR rate in each group.

    Time frame: At 24 weeks after end of treatment

07

Study locations

7 sites
  • Show Chwan Memorial Hospital
    Changhua City, 500, Taiwan
  • Changhua Christian Hospital
    Changhua County, 500, Taiwan
  • Keelung Chang Gung Memorial Hospital
    Keelung City, 222, Taiwan
  • China Medical University Hospital
    Taichung City, 404, Taiwan
  • Tungs' Taichung MetroHarbor Hospital
    Taichung City, 435, Taiwan
  • Taipei Medical University - Shuang Ho Hospital
    Taipei County, 235, Taiwan
  • Linkou Medical Center, Chang Gung Memorial Hospital
    Taoyuan County, 333, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01639547
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
I-Shyan Sheen (Clinical Professor, Chang Gung Memorial Hospital) — Principal investigator
First posted
Jul 12, 2012
Start date
Jul 2012
Primary completion
Jul 2014
Completion
Jul 2014
Last update
Jul 29, 2015

Study contacts

I-Shyan Sheen, M.D.
principal investigator · Linkou Medical Center, Chang Gung Memorial Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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