Chronic Hepatitis CPhase 2/3SCIN-CNCT00624325
Subcutaneous Continuous Infusion of Interferon Alfa-2b and Ribavirin in Hepatitis C Genotype 1 Nonresponders
A Phase 2/3 study testing interferon alfa-2b in people with Chronic Hepatitis C, run by Foundation for Liver Research at 1 site in Netherlands.
Trial summary
For chronic hepatitis C patients unresponsive to previous (PEG-)IFN/RBV combination therapy we propose continuous subcutaneous administration of high-dose IFN-a2b (Intron A®) for 48 weeks in combination with 15 mg/kg/day RBV (Rebetol®) and optimal management of side effects in order to maintain the highest possible… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- interferon alfa-2b
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2007to Dec 2010
- Phase
- Phase 2/3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Hepatitis C genotype 1 unresponsive to (peg)interferon /ribavirin therapy
- In the past, peginterferon or conventional interferon plus ribavirin combination therapy for at least 12 weeks and less than 2-log HCV RNA decrease at week 12, HCV RNA positivity at week 24, breakthrough during therapy or relapse after therapy
- At least 12 weeks between end of (peg)interferon/ribavirin therapy and start of high-dose IFN/ribavirin therapy
- Persistent indication for antiviral therapy such as persistently elevated serum ALT or histological evidence of continuing or progressive fibrosis
- Age 18-60 years
Who cannot join
- Signs of progressive liver disease since end of previous therapy, beyond generally accepted criteria for HCV antiviral therapy:
- serum bilirubin >35 μmol/l, albumin <36 g/l, prothrombin time >4 sec prolonged or platelets <100,000/mm3
- decompensated cirrhosis (defined as jaundice in the presence of cirrhosis, ascites, gastric bleeding, esophageal varices or encephalopathy)
- Hepatic imaging (US, CT or MRI) with the evidence of hepatocellular carcinoma (hepatic imaging should be performed within 3 months prior to screening) or an alpha fetoprotein >50 ng/ml
- Other acquired or inherited causes of liver disease that could explain liver disease activity
- Co-infection with hepatitis B virus or human immunodeficiency virus (HIV)
Show all 17Show fewer
- Other significant medical illness that might interfere with this study: significant cardiovascular, pulmonary or renal dysfunction, malignancy other than skin basocellular carcinoma in previous 5 years, immunodeficiency syndromes (e.g.: HIV positivity, steroid therapy, organ transplants other than cornea and hair transplant)
- History of a severe seizure disorder or current anticonvulsant use
- History of thyroid disease poorly controlled on prescribed medications
- Contra-indications for IFN and/or ribavirin:
- Severe psychiatric disorder, such as major psychoses, suicidal ideation, suicidal attempt and/or manifest depression during previous (peg)interferon therapy. Severe depression would include the following: (a) subjects who have been hospitalized for depression, (b) subjects who have received electroconvulsive therapy for depression, or (c) subjects whose depression has resulted in a prolonged absence of work and/or significant disruption of daily functions. Subjects with a history of mild depression may be considered for entry into the protocol provided that a pretreatment assessment of the subject's mental status supports that the subject is clinically stable and that there is ongoing evaluation of the patient's mental status during the study
- Reactivation of immunological disorders during previous therapy
- Visual symptoms related to retinal abnormalities
- Pregnancy, breast-feeding or inadequate contraception
- Thalassemia, spherocytosis
- Substance abuse, such as alcohol (³80 gm/day) and I.V. drugs. If the subject has a history of substance abuse, to be considered for inclusion into the protocol, the subject must have abstained from using the abused substance for at least 2 years
- Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study
Trial locations and contacts
1 site in 1 country.
About this study
For chronic hepatitis C patients unresponsive to previous (PEG-)IFN/RBV combination therapy we propose continuous subcutaneous administration of high-dose IFN-a2b (Intron A®) for 48 weeks in combination with 15 mg/kg/day RBV (Rebetol®) and optimal management of side effects in order to maintain the highest possible dosages of both IFN-a2b and RBV for 48 weeks. We expect improved tolerability with continuous subcutaneous pump delivery of IFN-a2b compared to thrice weekly or daily subcutaneous injection of IFN-a2b, and increased antiviral activity and biologic potency due to sustained and higher levels of a fully potent interferon protein.
- Conditions
- Chronic Hepatitis C
- Being tested
- interferon alfa-2b
- Keywords
- genotype 1 nonresponders
- 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.
interferon alfa-2bDrug
Also called Intron A
12 MU daily continuously subcutaneous
interferon alfa-2bDrug
Also called Intron A
9 MU daily continuously subcutaneous
interferon alfa-2bDrug
Also called Intron A
6 MU daily continuously subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 12 MU interferon alfa-2b daily continuously subcutaneous in combination with 15 mg/kg/day ribavirin Receives: Drug: interferon alfa-2b |
| 2 | Experimental | 9 MU interferon alfa-2b daily continuously subcutaneous in combination with 15 mg/kg/day ribavirin Receives: Drug: interferon alfa-2b |
| 3 | Experimental | 6 MU interferon alfa-2b daily continuously subcutaneous in combination with 15 mg/kg/day ribavirin Receives: Drug: interferon alfa-2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of high-dose continuous subcutaneous infused IFN-a2b (serious adverse events, grade 4 NCI toxicity, percentage of patients completing treatment or reasons for dose adjustments).
Measured: 48 weeks
Secondary outcomes (5)
HCV RNA negativity at week 48 and 24 weeks after end of treatment
Measured: 48 weeks
Biological activity of IFN-a2b
Measured: 48 weeks
Pharmacokinetics by IFN-a2b levels
Measured: 48 weeks
HCV-specific immune responses
Measured: 48 weeks
Quality of life assessment using SF-36 and SCL-90 questionnaires
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startJul 2007
- Primary completionJun 2010
- Study completionDec 2010
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Liver Research
- Sponsor type
- University, hospital or other
- Investigators
- R.J. de Knegt, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624325
- Sponsor's protocol ID
- HCV 06-01
- Other IDs
- eudract 2006-000592-15
- Acronym
- SCIN-C
- Status last verified
- Mar 2011
- First submitted
- 7 Jan 2008
- Last updated
- 11 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Continuous Infusion of Interferon Alfa-2b and Ribavirin in Hepatitis C Genotype 1 Nonresponders
- ClinicalTrials.gov ID
- NCT00624325
- Acronym / sponsor ID
- SCIN-C / HCV 06-01
- Conditions
- Chronic Hepatitis C
- Keywords
- genotype 1 nonresponders
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Foundation for Liver ResearchUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 27 Feb 2008 (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.
For chronic hepatitis C patients unresponsive to previous (PEG-)IFN/RBV combination therapy we propose continuous subcutaneous administration of high-dose IFN-a2b (Intron A®) for 48 weeks in combination with 15 mg/kg/day RBV (Rebetol®) and optimal management of side effects in order to maintain the highest possible dosages of both IFN-a2b and RBV for 48 weeks. We expect improved tolerability with continuous subcutaneous pump delivery of IFN-a2b compared to thrice weekly or daily subcutaneous injection of IFN-a2b, and increased antiviral activity and biologic potency due to sustained and higher levels of a fully potent interferon protein.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: interferon alfa-2b12 MU interferon alfa-2b daily continuously subcutaneous in combination with 15 mg/kg/day ribavirin |
| 2 | Experimental | Drug: interferon alfa-2b9 MU interferon alfa-2b daily continuously subcutaneous in combination with 15 mg/kg/day ribavirin |
| 3 | Experimental | Drug: interferon alfa-2b6 MU interferon alfa-2b daily continuously subcutaneous in combination with 15 mg/kg/day ribavirin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Hepatitis C genotype 1 unresponsive to (peg)interferon /ribavirin therapy
- In the past, peginterferon or conventional interferon plus ribavirin combination therapy for at least 12 weeks and less than 2-log HCV RNA decrease at week 12, HCV RNA positivity at week 24, breakthrough during therapy or relapse after therapy
- At least 12 weeks between end of (peg)interferon/ribavirin therapy and start of high-dose IFN/ribavirin therapy
- Persistent indication for antiviral therapy such as persistently elevated serum ALT or histological evidence of continuing or progressive fibrosis
- Age 18-60 years
Key exclusion criteria (17 listed)
- Signs of progressive liver disease since end of previous therapy, beyond generally accepted criteria for HCV antiviral therapy:
- Hepatic imaging (US, CT or MRI) with the evidence of hepatocellular carcinoma (hepatic imaging should be performed within 3 months prior to screening) or an alpha fetoprotein >50 ng/ml
- Other acquired or inherited causes of liver disease that could explain liver disease activity
- Co-infection with hepatitis B virus or human immunodeficiency virus (HIV)
- Other significant medical illness that might interfere with this study: significant cardiovascular, pulmonary or renal dysfunction, malignancy other than skin basocellular carcinoma in previous 5 years, immunodeficiency syndromes (e.g.: HIV positivity, steroid therapy, organ transplants other than cornea and hair 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 |
|---|---|---|
| interferon alfa-2bAlso: Intron A12 MU daily continuously subcutaneous | Drug | 1 |
| interferon alfa-2bAlso: Intron A9 MU daily continuously subcutaneous | Drug | 2 |
| interferon alfa-2bAlso: Intron A6 MU daily continuously subcutaneous | Drug | 3 |
Primary outcome
Safety and tolerability of high-dose continuous subcutaneous infused IFN-a2b (serious adverse events, grade 4 NCI toxicity, percentage of patients completing treatment or reasons for dose adjustments).
Time frame: 48 weeks
5 secondary outcomes
HCV RNA negativity at week 48 and 24 weeks after end of treatment
Time frame: 48 weeks
Biological activity of IFN-a2b
Time frame: 48 weeks
Pharmacokinetics by IFN-a2b levels
Time frame: 48 weeks
HCV-specific immune responses
Time frame: 48 weeks
Quality of life assessment using SF-36 and SCL-90 questionnaires
Time frame: 48 weeks
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 11 Mar 2011.
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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.
R.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 2/3 study testing interferon alfa-2b in people with Chronic 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 5 inclusion and 17 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 11 Mar 2011. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety and tolerability of high-dose continuous subcutaneous infused IFN-a2b (serious adverse events, grade 4 NCI toxicity, percentage of patients completing treatment or reasons for dose adjustments). (time frame: 48 weeks). 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 11 Mar 2011.