Chronic Hepatitis CNCT01639547
Sustained Virological Response (SVR)Rate of Pegasys Plus Ribavirin in Patients With Chronic Hepatitis C
A study testing Peginterferon alfa-2a plus Ribavirin in people with Chronic Hepatitis C, run by Chang Gung Memorial Hospital at 7 sites in Taiwan.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Peginterferon alfa-2a plus Ribavirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 7 sitesTaiwan
- Study dates
- Jul 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Taiwan7 sites
Show Chwan Memorial Hospital
Changhua, 500
Changhua Christian Hospital
Changhua County, 500
Keelung Chang Gung Memorial Hospital
Keelung, 222
China Medical University Hospital
Taichung, 404
Tungs' Taichung MetroHarbor Hospital
Taichung, 435
Taipei Medical University - Shuang Ho Hospital
Taipei County, 235
Linkou Medical Center, Chang Gung Memorial Hospital
Taoyuan County, 333
About this study
Official title: A Randomized, Open-lable, Multicenter, Parallel Group Study to Compare SVR Rate of Pegasys Plus Ribavirin for 48 Weeks vs. 36 Weeks in Patients With Chronic Hepatitis C
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.
- Conditions
- Chronic Hepatitis C
- Being tested
- Peginterferon alfa-2a plus Ribavirin
- Keywords
- PEGASYS® PLUS RIBAVIRIN
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon alfa-2a plus RibavirinDrug
Also called PEGASYS® plus ROBATROL®
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
| Study group | Role | What they receive |
|---|---|---|
| PEGASYS® plus ROBATROL® for 36 weeks | Experimental | Not described Receives: Drug: Peginterferon alfa-2a plus Ribavirin |
| PEGASYS® plus ROBATROL® for 48 weeks | Active comparator | Not described Receives: Drug: Peginterferon alfa-2a plus Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 24 weeks after end of treatment
Secondary outcomes (3)
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.
Measured: At treatment week 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).
Measured: At end of treatment
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.
Measured: At 24 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: early termination due to difficult collection of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, I-Shyan Sheen, Chang Gung Memorial Hospital
- Investigators
- I-Shyan Sheen, M.D., Principal investigator, Linkou Medical Center, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639547
- Sponsor's protocol ID
- CTC-133
- Status last verified
- Jul 2015
- First submitted
- 28 Jun 2012
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-lable, Multicenter, Parallel Group Study to Compare SVR Rate of Pegasys Plus Ribavirin for 48 Weeks vs. 36 Weeks in Patients With Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT01639547
- Acronym / sponsor ID
- CTC-133
- Conditions
- Chronic Hepatitis C
- Keywords
- PEGASYS® PLUS RIBAVIRIN
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: early termination due to difficult collection of patients
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 12 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peginterferon alfa-2a plus RibavirinAlso: PEGASYS® plus ROBATROL®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 | Drug | PEGASYS® plus ROBATROL® for 36 weeks, PEGASYS® plus ROBATROL® for 48 weeks |
Primary outcome
Sustained virological response
Time frame: At 24 weeks after end of treatment
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.
3 secondary outcomes
Virological Response Rate at week 2
Time frame: At treatment week 2
Virological response at end of treatment
Time frame: At end of treatment
Correlation of virological response and SVR rate
Time frame: At 24 weeks after end of treatment
Results and safety
The study was stopped early (reason given: early termination due to difficult collection of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
I-Shyan Sheen, M.D. principal investigator
Linkou Medical Center, Chang Gung Memorial Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peginterferon alfa-2a plus Ribavirin in people with Chronic Hepatitis C, run by Chang Gung Memorial Hospital at 7 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: early termination due to difficult collection of patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained virological response (time frame: At 24 weeks after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2015.