Liver CirrhosisPhase 3NCT00304551
A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Chronic Hepatitis C (CHC) Patients With Compensated Liver Cirrhosis (LC)
A Phase 3 study testing peginterferon alfa-2a 180μg, peginterferon alfa-2a 90μg and ribavirin in people with Liver Cirrhosis and Chronic Hepatitis C, run by Chugai Pharmaceutical at 8 sites in Japan.
Trial summary
This study evaluated the clinical response of the efficacy and safety of the combination therapy of peginterferon alfa-2a and ribavirin, compared with an antiviral treatment-free group in CHC patients with compensated LC. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Liver Cirrhosis, Chronic Hepatitis C
- What is being tested?
- peginterferon alfa-2a 180μg, peginterferon alfa-2a 90μg and ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 8 sitesJapan
- Study dates
- Jun 2006to Jun 2010
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20 to 75 years-old with quantifiable serum HCV-RNA (≥ 500 IU/mL), elevated serum alanine aminotransferase activity (≥ 45 IU per liter) within sixty days of screening, and proven CHC with compensated LC (Child-Pugh A) on liver biopsy.
Who cannot join
- Patients with neutropenia (fewer than 1,500 neutrophils per cubic millimeter)
- Thrombocytopenia (fewer than 75,000 platelets per cubic millimeter)
- Anemia (less than 12 g hemoglobin per deciliter )
- Hepatitis B co-infection; decompensated liver disease.
- Organ transplant
- Creatinine clearance less than 50 milliliters per minute
Show all 12Show fewer
- Poorly controlled psychiatric disease
- Poorly controlled diabetes
- Malignant neoplastic disease
- Severe cardiac or chronic pulmonary disease
- Immunologically mediated disease
- Retinopathy
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Chugoku
Chugoku
Hokkaido Region
Hokkaido
Kanto Region
Kanto
Kinki Region
Kinki
Kyusyu Region
Kyusyu
Shikoku Region
Shikoku
Tohoku Region
Tōhoku
Tokai Region
Tōkai
About this study
Official title: A Phase II/III Study of Peginterferon Alfa-2a in Combination With Ribavirin for the Treatment of CHC With Compensated LC
This study evaluated the clinical response of the efficacy and safety of the combination therapy of peginterferon alfa-2a and ribavirin, compared with an antiviral treatment-free group in CHC patients with compensated LC.
Additionally, this study evaluated the dosage reactivity and the pharmacokinetic characteristics of the combination therapy of peginterferon alfa-2a and ribavirin in CHC patients with compensated LC.
- Conditions
- Liver Cirrhosis, Chronic Hepatitis C
- Being tested
- peginterferon alfa-2a 180μg, peginterferon alfa-2a 90μg, ribavirin
- Keywords
- CHC with compensated LC
- Medical subject headings
- Liver Cirrhosis, 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 180μgDrug
180μg（s.c.）/week for 48 weeks
peginterferon alfa-2a 90μgDrug
90μg(s.c.)/week for 48 weeks
ribavirinDrug
600, 800, or 1,000 mg X 2(p.o.)/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: peginterferon alfa-2a 180μg; Drug: ribavirin |
| 2 | Experimental | Not described Receives: Drug: peginterferon alfa-2a 90μg; Drug: ribavirin |
| 3 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virological response, defined as undetectable hepatitis C virus (HCV)-RNA (< 50 IU per milliliter [IU/mL])
Measured: week 24 from the end of treatment
Secondary outcomes (2)
Biochemical response (normalization of serum alanine aminotransferase activity)
Measured: at the end of treatment and week 24 form the end of treatment
Virological response (HCV-RNA < 50 IU per milliliter)
Measured: at the end of treatment and week 24 form the 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 posted20 Mar 2006 (estimated)
- Study startJun 2006
- Primary completionDec 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Takehiko Aoshima, Study director, Clinical Research Department 4, Chugai Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00304551
- Sponsor's protocol ID
- JV19595
- Status last verified
- Jun 2010
- First submitted
- 5 Mar 2006
- Last updated
- 3 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III Study of Peginterferon Alfa-2a in Combination With Ribavirin for the Treatment of CHC With Compensated LC
- ClinicalTrials.gov ID
- NCT00304551
- Acronym / sponsor ID
- JV19595
- Conditions
- Liver Cirrhosis, Chronic Hepatitis C
- Keywords
- CHC with compensated LC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 20 Mar 2006 (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.
This study evaluated the clinical response of the efficacy and safety of the combination therapy of peginterferon alfa-2a and ribavirin, compared with an antiviral treatment-free group in CHC patients with compensated LC.
Additionally, this study evaluated the dosage reactivity and the pharmacokinetic characteristics of the combination therapy of peginterferon alfa-2a and ribavirin in CHC patients with compensated LC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: peginterferon alfa-2a 180μg, Drug: ribavirin |
| 2 | Experimental | Drug: peginterferon alfa-2a 90μg, Drug: ribavirin |
| 3 | No intervention | – |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 20 to 75 years-old with quantifiable serum HCV-RNA (≥ 500 IU/mL), elevated serum alanine aminotransferase activity (≥ 45 IU per liter) within sixty days of screening, and proven CHC with compensated LC (Child-Pugh A) on liver biopsy.
Key exclusion criteria (12 listed)
- Patients with neutropenia (fewer than 1,500 neutrophils per cubic millimeter)
- Thrombocytopenia (fewer than 75,000 platelets per cubic millimeter)
- Anemia (less than 12 g hemoglobin per deciliter )
- Hepatitis B co-infection; decompensated liver disease.
- Organ transplant
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 180μg180μg（s.c.）/week for 48 weeks | Drug | 1 |
| peginterferon alfa-2a 90μg90μg(s.c.)/week for 48 weeks | Drug | 2 |
| ribavirin600, 800, or 1,000 mg X 2(p.o.)/day | Drug | 1, 2 |
Primary outcome
Sustained virological response, defined as undetectable hepatitis C virus (HCV)-RNA (< 50 IU per milliliter [IU/mL])
Time frame: week 24 from the end of treatment
2 secondary outcomes
Biochemical response (normalization of serum alanine aminotransferase activity)
Time frame: at the end of treatment and week 24 form the end of treatment
Virological response (HCV-RNA < 50 IU per milliliter)
Time frame: at the end of treatment and week 24 form the end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2010.
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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.
Takehiko Aoshima study director
Clinical Research Department 4, Chugai Pharmaceutical Co., Ltd.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing peginterferon alfa-2a 180μg, peginterferon alfa-2a 90μg and ribavirin in people with Liver Cirrhosis and Chronic Hepatitis C, run by Chugai Pharmaceutical at 8 sites in Japan.
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 1 inclusion and 12 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: finished, as of the sponsor's last update on 3 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Japan. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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, defined as undetectable hepatitis C virus (HCV)-RNA (< 50 IU per milliliter [IU/mL]) (time frame: week 24 from the 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 3 Jun 2010.