Hepatitis CPhase 3NCT00363259
Pegintron Induction Therapy in HCV Non-Responders
A Phase 3 study testing Peginterferon alfa-2b and Ribavirin in people with Hepatitis C, run by Foundation for Liver Research at 7 sites in Netherlands.
Trial summary
The purpose of this study is to compare the sustained virological response rate at 24 weeks after the end of experimental treatment (induction and 72 weeks) to that of standard 48 weeks treatment with PEG-inteferon alfa-2b and ribavirin in patients with chronic hepatitis C previous unresponsive to interferon alfa… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Peginterferon alfa-2b and Ribavirin
- How many people
- 110 participants
- Where
- 7 sitesNetherlands
- Study dates
- Jul 2002to Nov 2005
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic hepatitis C
- non-response or relapse to previous interferon therapy with or without ribavirin for at least 3 months at any previous time
- detectable serum HCV-RNA
- elevated serum ALT activity documented on at least two occasions within the past 12 months, with at least one during the 90 day screening period preceding the initiation of test drug dosing
- liver biopsy findings (during screening or within previous 12 months) consistent with active fibrosis (haemophiliacs are excluded from biopsies)
- compensated liver disease (Child-Pugh Grade A clinical classification)
- negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
- all fertile males and females receiving ribavirin and their fertile or potentially fertile partners must be advised to use two forms of effective contraception (combined) during treatment and during the 6 months after end of treatment
Who cannot join
- history or other evidence of severe illness, malignancy or any other condition which would make the patient, in the opinion of the investigator, unsuitable for the study
- women with ongoing pregnancy or breast feeding
- therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) <3 months prior to the first dose of study drug
- any investigational drug <6 weeks prior to the first dose of study drug
- positive test at screening for HBsAg, anti-HIV Ab
- history or other evidence of bleeding from esophageal varices, ascites, or other conditions consistent with decompensated liver disease (Child-Pugh Grade B or C clinical classification)
Show all 23Show fewer
- Signs or symptoms of hepatocellular carcinoma
- history or other strong evidence of a medical condition associated with chronic liver disease other than HCV (e.g., primary hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures
- Hb <7.5 mmol/l in women or <8.6 mmol/l in men at screening
- any patient with an increased baseline risk for anaemia (e.g. thalassemia, spherocytosis, etc) or for whom anaemia would be medically problematic
- neutrophil count <1500 cells/mm3 or platelet count <80,000 cells/mm3 at screening
- serum creatinine level >1.5 times the upper limit of normal at screening
- history of severe psychiatric disease, especially depression
- history of a severe seizure disorder or current anticonvulsant use
- history of immunologically mediated disease
- history or other evidence of chronic pulmonary disease associated with functional limitation
- history of severe allergies
- history of symptomatic and/or significant cardiovascular disease
- poorly controlled diabetes mellitus
- history of major organ transplantation with an existing functional graft
- hyper- or hypothyroidism
- evidence of severe retinopathy
- evidence of drug abuse (including excessive alcohol consumption within one year before study entry
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Netherlands7 sites
OLVG
Amsterdam, 1091HA
Rijnstate Ziekenhuis
Arnhem, 6815 AN
Atrium Medisch Centrum
Heerlen, 6401 CX
LUMC
Leiden, 2300 RC
Erasmus MC
Rotterdam, 3000 CA
Ziekenhuis Zeeuws Vlaanderen
Terneuzen, 4535 PA
UMC
Utrecht, 3584 CX
About this study
Official title: Pegintron Induction Therapy in Previous Non-Responders With Chronic HCV: A Dutch Multicenter Randomized Controlled Trial. (PIT-Study)
The purpose of this study is to compare the sustained virological response rate at 24 weeks after the end of experimental treatment (induction and 72 weeks) to that of standard 48 weeks treatment with PEG-inteferon alfa-2b and ribavirin in patients with chronic hepatitis C previous unresponsive to interferon alfa monotherapy or interferon alfa/ribavirin combination therapy.
- Conditions
- Hepatitis C
- Being tested
- Peginterferon alfa-2b, Ribavirin
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon alfa-2bDrug
RibavirinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
sustained virological response (HCV-RNA negative 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 posted15 Aug 2006 (estimated)
- Study startJul 2002
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 110 participants
Sponsor and investigators
- Lead sponsor
- Foundation for Liver Research
- Sponsor type
- University, hospital or other
- Investigators
- Rob J de Knegt, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363259
- Sponsor's protocol ID
- HCV01-01
- Status last verified
- Aug 2006
- First submitted
- 10 Aug 2006
- Last updated
- 15 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pegintron Induction Therapy in Previous Non-Responders With Chronic HCV: A Dutch Multicenter Randomized Controlled Trial. (PIT-Study)
- ClinicalTrials.gov ID
- NCT00363259
- Acronym / sponsor ID
- HCV01-01
- Conditions
- Hepatitis C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants
- Lead sponsor
- Foundation for Liver ResearchUniversity, hospital or other
- Study start
- Jul 2002
- Study completion
- Nov 2005
- First posted
- 15 Aug 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.
The purpose of this study is to compare the sustained virological response rate at 24 weeks after the end of experimental treatment (induction and 72 weeks) to that of standard 48 weeks treatment with PEG-inteferon alfa-2b and ribavirin in patients with chronic hepatitis C previous unresponsive to interferon alfa monotherapy or interferon alfa/ribavirin combination therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- chronic hepatitis C
- non-response or relapse to previous interferon therapy with or without ribavirin for at least 3 months at any previous time
- detectable serum HCV-RNA
- elevated serum ALT activity documented on at least two occasions within the past 12 months, with at least one during the 90 day screening period preceding the initiation of test drug dosing
- liver biopsy findings (during screening or within previous 12 months) consistent with active fibrosis (haemophiliacs are excluded from biopsies)
Key exclusion criteria (23 listed)
- history or other evidence of severe illness, malignancy or any other condition which would make the patient, in the opinion of the investigator, unsuitable for the study
- women with ongoing pregnancy or breast feeding
- therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) <3 months prior to the first dose of study drug
- any investigational drug <6 weeks prior to the first dose of study drug
- positive test at screening for HBsAg, anti-HIV Ab
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-2b | Drug | – |
| Ribavirin | Drug | – |
Primary outcome
sustained virological response (HCV-RNA negative 24 weeks after 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 15 Aug 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.
Rob J de Knegt, MD, PhD principal investigator
Erasmus Medical Center
7 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-2b and Ribavirin in people with Hepatitis C, run by Foundation for Liver Research at 7 sites in Netherlands.
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 23 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 15 Aug 2006. 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 Netherlands. 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 (HCV-RNA negative 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 15 Aug 2006.