Chronic Hepatitis CPhase 4RelapCNCT00641654
Combination Therapy With Pegylated Interferon and Ribavirin in Patients With Chronic Hepatitis C Genotype 2 or 3 Infection Who Previously Have Relapsed After Therapy With Pegylated Interferon and Ribavirin
A Phase 4 study testing Pegylated interferon alfa-2a and ribavirin in people with Chronic Hepatitis C, run by Göteborg University at 1 site in Sweden.
Trial summary
To evaluate the efficacy of pegylated interferon alfa-2a 40 kD (PEGASYS) combination therapy with ribavirin (Copegus)given for 24 or 48 weeks in patients with chronic hepatitis C (CHC) virus infection genotype 2 or 3 who responded during (i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Pegylated interferon alfa-2a and ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2007to Dec 2009
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients ≥ 18 years of age
- Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
- Serum HCV-RNA ≥ 15 IU/mL. HCV genotype 2 or/and 3 infection confirmed within the past 6 months preceding the initiation of test drug dosing. The HCV genotype must have been reconfirmed after the termination of the previous treatment period
- Previous relapse (i.e. HCV-RNA < 50 IU/mL at end of previous therapy) after one treatment period with pegylated interferon alfa-2a or alfa-2b combination therapy with ribavirin for at least 12 weeks and at most 24 weeks
- A minimum of 24 weeks must have elapsed since the last dose of pegylated interferon or ribavirin in the previous treatment period before the patients can be included in this study
- Compensated liver disease (Child-Pugh Grade A clinical classification)
Show all 10Show fewer
- Patients with suspected cirrhosis or transition to cirrhosis must have an abdominal ultrasound, CT scan, or MRI scan without evidence of hepatocellular carcinoma and a serum AFP < 100 ng/mL within 2 months of randomization
- 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 must be using effective contraception during treatment and during the 6 months after treatment end
- Having a liver biopsy obtained within 5 years of this study is encouraged, but optional in accordance with local treatment traditions.
Who cannot join
- Women with ongoing pregnancy or breast feeding
- Previous non-response during treatment (as defined as having detectable HCV RNA ≥ 50 IU/ml at the end of previous treatment) with pegylated interferon alfa-2a or alfa-2b combination therapy with ribavirin for at least 12 weeks and at most 24 weeks
- Less than 24 weeks have elapsed since the last dose of pegylated interferon or ribavirin in the previous treatment period prior to inclusion in this study.
- Therapy with any systemic anti-viral
- anti-neoplastic
- immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) ≤ 6 months prior to the first dose of study drug
Show all 33Show fewer
- Any investigational drug ≤ 6 weeks prior to the first dose of study drug. HCV genotype 1, 4, 5 or 6 infection
- Positive test at screening for anti-HAV IgM Ab
- HBsAg
- anti-HBc IgM Ab
- anti-HIV Ab
- Evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
- History or other evidence of decompensated liver disease
- Neutrophil count < 1500 cells/mm3 or platelet count < 75,000 cells/mm3 at screening
- Serum creatinine level > 2 mg/dl (> 124 µmol/L) or creatinine clearance < 50 ml/minute at screening
- Severe psychiatric disease, especially depression, as judged by the treating physician
- History of a severe seizure disorder or current anticonvulsant use
- History of immunologically mediated disease
- severe chronic pulmonary disease associated with functional limitation
- severe cardiac disease
- major organ transplantation or other evidence of severe illness
- malignancy
- any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
- Thyroid dysfunction not adequately controlled (TSH and T4 levels out of normal range)
- Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration) or
- clinically relevant ophthalmological disorder due to diabetes mellitus or
- hypertension
- Evidence of drug abuse (including excessive alcohol consumption) in accordance with local therapeutic traditions. (Patients receiving Methadone or Subutex therapy may be included in this study.)
- Inability or unwillingness to provide informed consent or abide by the requirements of the study
- Male partners of women who are pregnant
- Hemoglobin < 11.3 g/dL (< 7.0 mmol/L) in women or < 12.9 g/dL (< 8.0 mmol/L) in men at screening.
- Any patient with an increased baseline risk for anemia (e.g. thalassemia, spherocytosis, etc) or for whom anemia would be medically problematic
- Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (as may be seen with ribavirin therapy) would not be well-tolerated
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept of Infectious Diseases, Sahlgrenska University Hospital
Gothenburg, SE-416 85
About this study
Official title: An Open-label Multicenter Study Evaluating the Efficacy and Safety of 24 or 48 Weeks Pegylated Interferon Alfa-2a 40 kD (PEGASYS) Combination Therapy With Ribavirin (Copegus) in Patients With Chronic Hepatitis C Genotype 2 or 3 Infection Who Previously Have Relapsed After a Minimum of 12 Weeks and a Maximum of 24 Weeks of Therapy With Pegylated Interferon and Ribavirin
To evaluate the efficacy of pegylated interferon alfa-2a 40 kD (PEGASYS) combination therapy with ribavirin (Copegus)given for 24 or 48 weeks in patients with chronic hepatitis C (CHC) virus infection genotype 2 or 3 who responded during (i.e. had HCV-RNA <50 IU/mL at the end of previous therapy), but relapsed after (i.e. had detectable HCV-RNA after the end of prior treatment) previous therapy with pegylated interferon and ribavirin given for at least 12 weeks and at most 24 weeks.
- Conditions
- Chronic Hepatitis C
- Being tested
- Pegylated interferon alfa-2a and ribavirin
- Keywords
- Chronic hepatitis C, genotype 2 or 3, relapse, pegylated interferon, ribavirin
- Medical subject headings
- Hepatitis C, Chronic, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated interferon alfa-2a and ribavirinDrug
Also called Pegasys, Copegus
Arm A: Pegylated interferon alfa-2a Injection, 180 µg sc x 1/w for 48 weeks Ribavirin Tablet 200 mg weight based 5 or 6 per day for 48 weeks
Pegylated interferon alfa-2a and ribavirinDrug
Also called Pegasys, Copegus
Arm B:Pegylated interferon alfa-2a Injection, 180 µg sc x 1/w for 48 weeks Ribavirin Tablet 200 mg weight based 5 or 6 per day for 48 weeks
Pegylated interferon alfa-2a and ribavirinDrug
Also called Pegasys, Copegus
Arm C:Pegylated interferon alfa-2a Injection, 180 µg sc x 1/w for 24 weeks Ribavirin Tablet 200 mg weight based 5 or 6 per day for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Patients having previously received 24 weeks of therapy with pegylated interferon and ribavirin will be treated with pegylated interferon alfa-2a kD (PEGASYS) plus ribavirin, (Copegus) for a treatment period of 48 weeks, with a follow-up period of 24 weeks irrespective of the level of HCV-RNA measured in plasma on treatment day 27. Receives: Drug: Pegylated interferon alfa-2a and ribavirin |
| B | Active comparator | Patients having previously received less than 24 weeks but at least 12 weeks of therapy with pegylated interferon and Ribavirin and having detectable HCV-RNA in a plasma sample obtained on treatment day 27 (i.e. the day before the 5th dose of pegylated interferon in this study) as analyzed by means of COBAS TaqMan 48TM will be treated with pegylated interferon alfa-2a KD (PEGASYS®) plus ribavirin, (Copegus®) for a treatment period of 48 weeks, with a follow-up period of 24 weeks. Receives: Drug: Pegylated interferon alfa-2a and ribavirin |
| C | Active comparator | Patients having previously received less than 24 weeks but at least 12 weeks of therapy with pegylated interferon and Ribavirin and having undetectable HCV-RNA in a plasma sample obtained on treatment day 27 (i.e. the day before the 5th dose of pegylated interferon in this study) as analyzed by means of COBAS TaqMan 48TM will be treated with pegylated interferon alfa-2a KD (PEGASYS®) plus ribavirin, (Copegus®) for a treatment period of 24 weeks, with a follow-up period of 24 weeks. Receives: Drug: Pegylated interferon alfa-2a and ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained viral response (SVR) rate defined as percentage of patients with non-detectable HCV-RNA 24 weeks after completion of the 24 or 48 week treatment period.
Measured: 24 weeks after completion of the 24 or 48 week treatment period.
Secondary outcomes (1)
Sustained viral response (SVR)rate and percentage of patients with normal serum ALT levels and its association with prespecified factors e.g. viral load
Measured: 24 weeks after complection of the 24 or 48 week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startJan 2007
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: Recruitment problems in Denmark and Norway
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Gunnar PE Norkrans, MD Prof, Principal investigator, Sahlgrenska University Hospital,Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641654
- Sponsor's protocol ID
- EudractCT 2006-003409-18
- Acronym
- RelapC
- Status last verified
- Mar 2012
- First submitted
- 17 Mar 2008
- Last updated
- 30 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Lagging M, Rembeck K, Rauning Buhl M, Christensen P, Dalgard O, Farkkila M, Hellstrand K, Langeland N, Lindh M, Westin J, Norkrans G. Retreatment with peg-interferon and ribavirin in patients with chronic hepatitis C virus genotype 2 or 3 infection with prior relapse. Scand J Gastroenterol. 2013 Jul;48(7):839-47. doi: 10.3109/00365521.2013.793389.
PubMed 23795661
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Multicenter Study Evaluating the Efficacy and Safety of 24 or 48 Weeks Pegylated Interferon Alfa-2a 40 kD (PEGASYS) Combination Therapy With Ribavirin (Copegus) in Patients With Chronic Hepatitis C Genotype 2 or 3 Infection Who Previously Have Relapsed After a Minimum of 12 Weeks and a Maximum of 24 Weeks of Therapy With Pegylated Interferon and Ribavirin
- ClinicalTrials.gov ID
- NCT00641654
- Acronym / sponsor ID
- RelapC / EudractCT 2006-003409-18
- Conditions
- Chronic Hepatitis C
- Keywords
- Chronic hepatitis C, genotype 2 or 3, relapse, pegylated interferon, ribavirin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment problems in Denmark and Norway
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Jan 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 24 Mar 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.
To evaluate the efficacy of pegylated interferon alfa-2a 40 kD (PEGASYS) combination therapy with ribavirin (Copegus)given for 24 or 48 weeks in patients with chronic hepatitis C (CHC) virus infection genotype 2 or 3 who responded during (i.e. had HCV-RNA <50 IU/mL at the end of previous therapy), but relapsed after (i.e. had detectable HCV-RNA after the end of prior treatment) previous therapy with pegylated interferon and ribavirin given for at least 12 weeks and at most 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Pegylated interferon alfa-2a and ribavirinPatients having previously received 24 weeks of therapy with pegylated interferon and ribavirin will be treated with pegylated interferon alfa-2a kD (PEGASYS) plus ribavirin, (Copegus) for a treatment period of 48 weeks, with a follow-up period of 24 weeks irrespective of the level of HCV-RNA measured in plasma on treatment day 27. |
| B | Active comparator | Drug: Pegylated interferon alfa-2a and ribavirinPatients having previously received less than 24 weeks but at least 12 weeks of therapy with pegylated interferon and Ribavirin and having detectable HCV-RNA in a plasma sample obtained on treatment day 27 (i.e. the day before the 5th dose of pegylated interferon in this study) as analyzed by means of COBAS TaqMan 48TM will be treated with pegylated interferon alfa-2a KD (PEGASYS®) plus ribavirin, (Copegus®) for a treatment period of 48 weeks, with a follow-up period of 24 weeks. |
| C | Active comparator | Drug: Pegylated interferon alfa-2a and ribavirinPatients having previously received less than 24 weeks but at least 12 weeks of therapy with pegylated interferon and Ribavirin and having undetectable HCV-RNA in a plasma sample obtained on treatment day 27 (i.e. the day before the 5th dose of pegylated interferon in this study) as analyzed by means of COBAS TaqMan 48TM will be treated with pegylated interferon alfa-2a KD (PEGASYS®) plus ribavirin, (Copegus®) for a treatment period of 24 weeks, with a follow-up period of 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female patients ≥ 18 years of age
- Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
- Serum HCV-RNA ≥ 15 IU/mL. HCV genotype 2 or/and 3 infection confirmed within the past 6 months preceding the initiation of test drug dosing. The HCV genotype must have been reconfirmed after the termination of the previous treatment period
- Previous relapse (i.e. HCV-RNA < 50 IU/mL at end of previous therapy) after one treatment period with pegylated interferon alfa-2a or alfa-2b combination therapy with ribavirin for at least 12 weeks and at most 24 weeks
- A minimum of 24 weeks must have elapsed since the last dose of pegylated interferon or ribavirin in the previous treatment period before the patients can be included in this study
Key exclusion criteria (33 listed)
- Women with ongoing pregnancy or breast feeding
- Previous non-response during treatment (as defined as having detectable HCV RNA ≥ 50 IU/ml at the end of previous treatment) with pegylated interferon alfa-2a or alfa-2b combination therapy with ribavirin for at least 12 weeks and at most 24 weeks
- Less than 24 weeks have elapsed since the last dose of pegylated interferon or ribavirin in the previous treatment period prior to inclusion in this study.
- Therapy with any systemic anti-viral
- Any investigational drug ≤ 6 weeks prior to the first dose of study drug. HCV genotype 1, 4, 5 or 6 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 |
|---|---|---|
| Pegylated interferon alfa-2a and ribavirinAlso: Pegasys, CopegusArm A: Pegylated interferon alfa-2a Injection, 180 µg sc x 1/w for 48 weeks Ribavirin Tablet 200 mg weight based 5 or 6 per day for 48 weeks | Drug | A |
| Pegylated interferon alfa-2a and ribavirinAlso: Pegasys, CopegusArm B:Pegylated interferon alfa-2a Injection, 180 µg sc x 1/w for 48 weeks Ribavirin Tablet 200 mg weight based 5 or 6 per day for 48 weeks | Drug | B |
| Pegylated interferon alfa-2a and ribavirinAlso: Pegasys, CopegusArm C:Pegylated interferon alfa-2a Injection, 180 µg sc x 1/w for 24 weeks Ribavirin Tablet 200 mg weight based 5 or 6 per day for 24 weeks | Drug | C |
Primary outcome
Sustained viral response (SVR) rate defined as percentage of patients with non-detectable HCV-RNA 24 weeks after completion of the 24 or 48 week treatment period.
Time frame: 24 weeks after completion of the 24 or 48 week treatment period.
1 secondary outcome
Sustained viral response (SVR)rate and percentage of patients with normal serum ALT levels and its association with prespecified factors e.g. viral load
Time frame: 24 weeks after complection of the 24 or 48 week treatment
Results and safety
The study was stopped early (reason given: Recruitment problems in Denmark and Norway). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2012.
- Derived from this study: PubMed 23795661Lagging M, Rembeck K, Rauning Buhl M, Christensen P, Dalgard O, Farkkila M, Hellstrand K, Langeland N, Lindh M, Westin J, Norkrans G. Retreatment with peg-interferon and ribavirin in patients with chronic hepatitis C virus genotype 2 or 3 infection with prior relapse. Scand J Gastroenterol. 2013 Jul;48(7):839-47. doi: 10.3109/00365521.2013.793389.
Related trials for Chronic Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
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.
Gunnar PE Norkrans, MD Prof principal investigator
Sahlgrenska University Hospital,Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pegylated interferon alfa-2a and ribavirin in people with Chronic Hepatitis C, run by Göteborg University at 1 site in Sweden.
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 10 inclusion and 33 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: stopped early, as of the sponsor's last update on 30 Aug 2012. 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 Sweden. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Recruitment problems in Denmark and Norway). Results are not available in the source record.
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 viral response (SVR) rate defined as percentage of patients with non-detectable HCV-RNA 24 weeks after completion of the 24 or 48 week treatment period. (time frame: 24 weeks after completion of the 24 or 48 week treatment period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00641654, which also lists 1 linked publication.
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 30 Aug 2012.