Chronic Hepatitis CPhase 3NCT00336518
Continuing Treatment With Pegasys and Copegus
A Phase 3 study testing peginterferon alfa-2a and ribavirin in people with Chronic Hepatitis C, run by Májbetegekért Alapítvány at 1 site in Hungary.
Trial summary
Primary objective is to measure sustained viral response given to continuation or prolongation of combined Pegasys\&Copegus treatment Secondary objective is to measure histological response given to continuation or prolongation of combined Pegasys\&Copegus treatment measured by non-invasive methods Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- peginterferon alfa-2a and ribavirin
- How many people
- 100 participants
- Where
- 1 siteHungary
- Study dates
- Jun 2006to Jul 2009
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients above 18 and below 65 years of age chronically infected with genotype 1 HCV receiving combined Pegasys\&Copegus treatment first time in-line with the valid treatment guideline approved by the National Interferon Committee (see attached guideline)
- Subgroup 1:
- Positive HCV PCR result at week 12 of the ongoing treatment
- ALT > 1ULN, but the value decreased by week 12
- Subgroup 2:
- ALT was normal and PCR was positive at week 12, therefore combined treatment could be continued between week 12 and 24 based on the approved guideline
- Positive HCV RNA PCR at week 24 of the ongoing treatment
- GPT < 2 ULN at week 24 of the ongoing treatment.
Who cannot join
- Women with ongoing pregnancy or breast feeding
- Therapy with any systemic anti-neoplastic or immunomodulatory treatment at inclusion or within 6 months prior to it
- Any investigational drug usage at inclusion or within 6 weeks prior to it
- Co/infection with hepatitis A, B or HIV
- Any chronic liver disease other than HCV infection
- Sign or symptom of hepatocellular carcinoma
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- Decompensated liver disease
- History of depression or any other relevant psychiatric disease which, in the opinion of a psychiatrist or neurologist, contraindicates study therapy
- Uncontrolled thyroid dysfunction
- Severe retinopathy
- Evidence of regular alcohol consumption at inclusion or within 1 year prior to it
- Any side effect probably caused by ongoing combined treatment which, in the opinion of the investigator, contraindicates continuation of the therapy or necessitates dose reduction of any drug in the combination therapy
- Unwillingness to provide informed consent
- Subgroup 1:
- Laboratory findings at week 16 of the ongoing combined Pegasys\&Copegus treatment:
- ANC <1000/mm3
- PLT <75.000/mm3
- hemoglobin <10g/dl
- creatinine >1,5 ULN
- Subgroup 2:
- Laboratory findings at week 28 of the ongoing combined Pegasys\&Copegus treatment:
- ANC <1000/mm3
- PLT <75.000/mm3
- hemoglobin <10g/dl
- creatinine >1,5 ULN
Trial locations and contacts
1 site in 1 country.
János Schuller, Dr. contact
Edit Villert contact
Hungary1 site, 1 recruiting
- Recruiting
Szt. László Hospital
Budapest, 1097
János Schuller, Dr., +36 1 455-8228
Edit Villert, +36 1 455-8228
About this study
Official title: Efficacy and Safety of Continuing for a Total of 48 or Prolonging for a Total of 72 Weeks of Combined Treatment of Patients Receiving Pegasys and Copegus Who Are Biochemical Responders But Virological Non-Responders at Week 12 or Week 24
Primary objective is to measure sustained viral response given to continuation or prolongation of combined Pegasys\&Copegus treatment
Secondary objective is to measure histological response given to continuation or prolongation of combined Pegasys\&Copegus treatment measured by non-invasive methods
Read the detailed description
Prospective, multicentre, randomized, open-label comparative study
According to our national guideline of management of patient with chronic viral hepatitis, patients need to stop therapy if they do not achieve response.
These patients can enter to the study at two time points:
- at week 16, if HCV RNS PCR measured at week 12 is positive and serum ALT > 1ULN, but decreased
- at week 28, if HCV RNS PCR measured at week 24 is still positive, but serum ALT < 2ULN.
Patients are randomized to one of the following arms:
- S (standard) group: Pegasys\&Copegus combined therapy 180 mcg/week \& weight/based 1000-1200 mg/day for a total of 48 weeks of treatment
- P (prolonged) group: Pegasys\&Copegus combined therapy 180 mcg/week \& -weight/based 1000-1200 mg/day for a total of 72 weeks of treatment.
After completing treatment period patients enter into a 24-week follow up.
- Conditions
- Chronic Hepatitis C
- Being tested
- peginterferon alfa-2a, 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-2aDrug
ribavirinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained viral response given to continuation or prolongation of combined Pegasys&Copegus treatment
Secondary outcomes (1)
Histological response given to continuation or prolongation of combined Pegasys&Copegus treatment measured by non-invasive methods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2006 (estimated)
- Study startJun 2006
- Study completionJul 2009
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.
- 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
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Májbetegekért Alapítvány
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Investigators
- János Schuller, Dr., Principal investigator, Májbetegekért Alapítvány
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336518
- Sponsor's protocol ID
- MBA 1/2005
- Other IDs
- ML 20142, EuDract: 2005-004531-22
- Status last verified
- Aug 2005
- First submitted
- 12 Jun 2006
- Last updated
- 13 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Continuing for a Total of 48 or Prolonging for a Total of 72 Weeks of Combined Treatment of Patients Receiving Pegasys and Copegus Who Are Biochemical Responders But Virological Non-Responders at Week 12 or Week 24
- ClinicalTrials.gov ID
- NCT00336518
- Acronym / sponsor ID
- MBA 1/2005
- Conditions
- Chronic Hepatitis C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- Májbetegekért AlapítványUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Jun 2006
- Study completion
- Jul 2009
- First posted
- 13 Jun 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.
Primary objective is to measure sustained viral response given to continuation or prolongation of combined Pegasys\&Copegus treatment
Secondary objective is to measure histological response given to continuation or prolongation of combined Pegasys\&Copegus treatment measured by non-invasive methods
Detailed description
Prospective, multicentre, randomized, open-label comparative study
According to our national guideline of management of patient with chronic viral hepatitis, patients need to stop therapy if they do not achieve response.
These patients can enter to the study at two time points:
- at week 16, if HCV RNS PCR measured at week 12 is positive and serum ALT > 1ULN, but decreased
- at week 28, if HCV RNS PCR measured at week 24 is still positive, but serum ALT < 2ULN.
Patients are randomized to one of the following arms:
- S (standard) group: Pegasys\&Copegus combined therapy 180 mcg/week \& weight/based 1000-1200 mg/day for a total of 48 weeks of treatment
- P (prolonged) group: Pegasys\&Copegus combined therapy 180 mcg/week \& -weight/based 1000-1200 mg/day for a total of 72 weeks of treatment.
After completing treatment period patients enter into a 24-week follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female patients above 18 and below 65 years of age chronically infected with genotype 1 HCV receiving combined Pegasys\&Copegus treatment first time in-line with the valid treatment guideline approved by the National Interferon Committee (see attached guideline)
- Positive HCV PCR result at week 12 of the ongoing treatment
- ALT > 1ULN, but the value decreased by week 12
- ALT was normal and PCR was positive at week 12, therefore combined treatment could be continued between week 12 and 24 based on the approved guideline
- Positive HCV RNA PCR at week 24 of the ongoing treatment
Key exclusion criteria (25 listed)
- Women with ongoing pregnancy or breast feeding
- Therapy with any systemic anti-neoplastic or immunomodulatory treatment at inclusion or within 6 months prior to it
- Any investigational drug usage at inclusion or within 6 weeks prior to it
- Co/infection with hepatitis A, B or HIV
- Any chronic liver disease other than HCV infection
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 | Drug | – |
| ribavirin | Drug | – |
Primary outcome
Sustained viral response given to continuation or prolongation of combined Pegasys&Copegus treatment
1 secondary outcome
Histological response given to continuation or prolongation of combined Pegasys&Copegus treatment measured by non-invasive methods
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2006.
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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.
János Schuller, Dr. contact
Edit Villert contact
János Schuller, Dr. principal investigator
Májbetegekért Alapítvány
1 site 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 and ribavirin in people with Chronic Hepatitis C, run by Májbetegekért Alapítvány at 1 site in Hungary.
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 8 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 13 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact János Schuller, Dr. (+36 1 455-8127), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained viral response given to continuation or prolongation of combined Pegasys&Copegus 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 13 Jun 2006.