Hepatitis CPhase 3NCT00381953
High-dose IFN and PEG IFN for Induction Therapy in Difficult to Treat Genotype 1 Patients With Chronic HCV
A Phase 3 study testing Peginterferon alfa-2a, Interferon alfa-2a and Ribavirin in people with Hepatitis C, run by Foundation for Liver Research at 1 site in Netherlands.
Trial summary
Comparison of virological breakthrough/relapse rate after dose adjustments and sustained virological response rate will be assessed by the type of induction. 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-2a, Interferon alfa-2a and Ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2003to Jul 2006
- 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
- 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)
- 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
Show all 20Show fewer
- 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
1 site in 1 country.
About this study
Official title: A Comparative Study of High-dose Interferon Alfa-2a and Pegylated Interferon Alfa-2a for Induction Therapy in Difficult to Treat Genotype 1 Patients With Chronic HCV
Comparison of virological breakthrough/relapse rate after dose adjustments and sustained virological response rate will be assessed by the type of induction.
Read the detailed description
The purpose of this study is to compare pharmacokinetics by IFN assays and pharmacodynamics by patient's HCVRNA suppression of 360 mug peginterferon QW, 9 MU interferon daily or 4,5 MU interferon daily in combination with 180 mug peginterferon QW in the first 4 weeks of treatment. Comparison of virological breakthrough/relapse rate after dose adjustments and sustained virological response rate will be assessed by the type of induction.
- Conditions
- Hepatitis C
- Being tested
- Peginterferon alfa-2a, Interferon alfa-2a, 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-2aDrug
Also called Pegasys
Interferon alfa-2aDrug
Also called Intron-A
RibavirinDrug
Also called Copegus
| Study group | Role | What they receive |
|---|---|---|
| 360 PEG IFN | Active comparator | 360 mug peginterferon alfa-2a QW Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin |
| 9 MU + 180 PEG IFN | Active comparator | 9 MU interferon daily in combination with 180 mug peginterferon QW in the first 4 weeks of treatment Receives: Drug: Peginterferon alfa-2a; Drug: Interferon alfa-2a; Drug: Ribavirin |
| 4,5 MU IFN + 180 PEG IFN | Active comparator | 4,5 MU interferon daily in combination with 180 mug peginterferon QW in the first 4 weeks of treatment Receives: Drug: Peginterferon alfa-2a; Drug: Interferon alfa-2a; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare pharmacokinetics by IFN assays and pharmacodynamics by patient's HCV RNA suppression of 360 mug peginterferon alfa-2a QW, 9 MU interferon alfa-2a daily or 4,5 interferon alfa-2a daily in combination with 180 mug peginterferon alfa-2a QW
Measured: week 4
Secondary outcomes (2)
To compare the virological breakthrough/relapse rate after dose adjustments (at 4,24,72) weeks.
Measured: week 4, 24 and 72
To compare the sustained virological response rate at 24 weeks after end of treatment.
Measured: week 24 follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2006 (estimated)
- Study startFeb 2003
- Primary completionApr 2006
- Study completionJul 2006
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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Liver Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rob J. de Knegt, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381953
- Sponsor's protocol ID
- HCV02-01
- Status last verified
- Aug 2021
- First submitted
- 27 Sep 2006
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of High-dose Interferon Alfa-2a and Pegylated Interferon Alfa-2a for Induction Therapy in Difficult to Treat Genotype 1 Patients With Chronic HCV
- ClinicalTrials.gov ID
- NCT00381953
- Acronym / sponsor ID
- HCV02-01
- Conditions
- Hepatitis C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Foundation for Liver ResearchUniversity, hospital or other
- Study start
- Feb 2003
- Primary completion
- Apr 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 28 Sep 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.
Comparison of virological breakthrough/relapse rate after dose adjustments and sustained virological response rate will be assessed by the type of induction.
Detailed description
The purpose of this study is to compare pharmacokinetics by IFN assays and pharmacodynamics by patient's HCVRNA suppression of 360 mug peginterferon QW, 9 MU interferon daily or 4,5 MU interferon daily in combination with 180 mug peginterferon QW in the first 4 weeks of treatment. Comparison of virological breakthrough/relapse rate after dose adjustments and sustained virological response rate will be assessed by the type of induction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 360 PEG IFN | Active comparator | Drug: Peginterferon alfa-2a, Drug: Ribavirin360 mug peginterferon alfa-2a QW |
| 9 MU + 180 PEG IFN | Active comparator | Drug: Peginterferon alfa-2a, Drug: Interferon alfa-2a, Drug: Ribavirin9 MU interferon daily in combination with 180 mug peginterferon QW in the first 4 weeks of treatment |
| 4,5 MU IFN + 180 PEG IFN | Active comparator | Drug: Peginterferon alfa-2a, Drug: Interferon alfa-2a, Drug: Ribavirin4,5 MU interferon daily in combination with 180 mug peginterferon QW in the first 4 weeks of treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- chronic hepatitis C
- 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)
Key exclusion criteria (20 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 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)
- Signs or symptoms of hepatocellular carcinoma
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-2aAlso: Pegasys | Drug | 360 PEG IFN, 4,5 MU IFN + 180 PEG IFN, 9 MU + 180 PEG IFN |
| Interferon alfa-2aAlso: Intron-A | Drug | 4,5 MU IFN + 180 PEG IFN, 9 MU + 180 PEG IFN |
| RibavirinAlso: Copegus | Drug | 360 PEG IFN, 4,5 MU IFN + 180 PEG IFN, 9 MU + 180 PEG IFN |
Primary outcome
To compare pharmacokinetics by IFN assays and pharmacodynamics by patient's HCV RNA suppression of 360 mug peginterferon alfa-2a QW, 9 MU interferon alfa-2a daily or 4,5 interferon alfa-2a daily in combination with 180 mug peginterferon alfa-2a QW
Time frame: week 4
2 secondary outcomes
To compare the virological breakthrough/relapse rate after dose adjustments (at 4,24,72) weeks.
Time frame: week 4, 24 and 72
To compare the sustained virological response rate at 24 weeks after end of treatment.
Time frame: week 24 follow up
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 1 Sep 2021.
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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
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, Interferon alfa-2a and Ribavirin in people with Hepatitis C, run by Foundation for Liver Research at 1 site 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 7 inclusion and 20 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 1 Sep 2021. 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 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?
To compare pharmacokinetics by IFN assays and pharmacodynamics by patient's HCV RNA suppression of 360 mug peginterferon alfa-2a QW, 9 MU interferon alfa-2a daily or 4,5 interferon alfa-2a daily in combination with 180 mug peginterferon alfa-2a QW (time frame: week 4). 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 1 Sep 2021.