Hepatitis CPhase 2PARTNERNCT00512278
Infliximab Treatment Along With Pegylated Interferon and Ribavirin in the Treatment of Hepatitis C
A Phase 2 study testing Infliximab in people with Hepatitis C, run by Nizar Zein at 7 sites in United States.
Trial summary
The aim of the study is to investigate in subjects receiving their first course of peg-interferon α-2b plus ribavirin therapy for chronic HCV infection Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Infliximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 7 sitesUnited States
- Study dates
- Jul 2007to May 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 or female subjects, >18 years of age with proven chronic (greater than 6 months) hepatitis C infection (genotype 1) who have never been treated with pegylated interferon α-2b and /or ribavirin.
- Criteria for inclusion in this trial are as follows:
- Male or female, 18 years of age or older
- Positive HCV RNA, Genotype 1, treatment naïve (never received pegylated interferon and / or ribavirin)
- Evidence of chronic HCV infection for at least six months prior to screening
- Findings on liver biopsy within the past 36 months that are consistent with the presence of chronic hepatitis C infection.
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- Negative hepatitis B surface antigen
- No evidence of hemochromatosis
- Hemoglobin ≥12 g/dL for females and ≥13 g/dL for males
- WBC ≥3.0 x 109/L and neutrophils ≥1.5 x 109/L
- Platelets ≥80 x109/L
- Direct Bilirubin WNL +/- 50% of central laboratory normal range. Total bilirubin ≤1.6.
- Albumin within normal limits
- Serum creatinine within normal limits.
- Serum thyroid stimulating hormone (TSH) levels within normal limits
- Men and women of childbearing potential must use two forms of adequate birth control measures for the duration of the study and should continue such precautions for 6 months after receiving the last infusion.
- Subjects with a history of mild depression may be considered for entry into this study.
- No history of latent or active TB.
Who cannot join
- Women who are pregnant, nursing, or planning pregnancy within 6 months after the last infusion and men with partners who are pregnant at baseline or intend to become pregnant within 6 months after the last infusion.
- Known allergy against infliximab, ribavirin, or pegylated interferon
- Decompensated liver disease characterized as decreased hepatic synthetic functioning with abnormal albumin and bilirubin levels, prolonged prothrombin time or complications including ascites or recent variceal bleeding
- have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidiomycosis (Valley Fever)
- History of autoimmune hepatitis or a history of poorly controlled autoimmune disease
- Use of other systemic anti-inflammatory medication except NSAIDs and low dose systemic steroids
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- Previous treatment with monoclonal antibodies or antibody fragments
- History of receiving human/murine recombinant products or a known allergy to murine products
- Documentation of seropositive for human immunodeficiency virus (HIV)
- History of alcohol or substance abuse within the preceding 6 months that, in the opinion of the investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results
- History of serious infections (e.g., hepatitis, pneumonia or pyelonephritis) in the previous 3 months
- Opportunistic infection within 6 months prior to screening
- History of lymphoproliferative disease
- Currently have any known malignancy or have a history of malignancy within the previous 5 years, with the exception of basal cell or squamous cell carcinoma of the skin that has been fully excised with no evidence of recurrence
- Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease
- Treatment with any other therapeutic agent targeted at reducing TNF within 3 months of screening
- Presence of a transplanted solid organ
- Concomitant diagnosis or history of congestive heart failure
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Case Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
The Liver Institute at Methodist Dallas
Dallas, Texas, 75203
Cedars-Sinai Medical Center, Center for Liver Disease and Transplantation
Los Angeles, California, 90048
University of Louisville
Louisville, Kentucky, 440292
Advanced Medical Research Center
Port Orange, Florida, 32127
Brooke Army Medical Center
San Antonio, Texas, 78234
About this study
Official title: Infliximab (Remicade®) as an Adjunct to Pegylated- Interferon α-2b and Ribavirin in the Treatment of Hepatitis C Virus Infection
The aim of the study is to investigate in subjects receiving their first course of peg-interferon α-2b plus ribavirin therapy for chronic HCV infection
Read the detailed description
The aim of the study is to investigate in subjects receiving their first course of peg-interferon α-2b plus ribavirin therapy for chronic HCV infection (genotype 1) whether the addition of infliximab to a standard regimen of pegylated interferon α-2b in combination with ribavirin:
- increases the proportion of subjects attaining a sustained virological response SVR (undetectable blood Hepatitis C viral load 6 months after treatment)
- improves the safety profile compared to the same regimen without infliximab
- Conditions
- Hepatitis C
- Being tested
- Infliximab, Placebo
- Keywords
- Hepatitis, HCV, Hepatitis C
- Medical subject headings
- Hepatitis C, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
Also called Remicade
Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Infliximab | Experimental | Infliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab Receives: Drug: Infliximab |
| Placebo | Placebo comparator | Placebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Comparison of the Percentage of Chronic Hepatitis C Subjects (Treatment Naive,Genotype 1) Who Achieve SVR at Week 72, After 48 Weeks of Treatment.
A comparison of the Proportion of Chronic Hepatitis C Subjects (Treatment Naive,Genotype 1) Who Achieve SVR at Week 72, After 48 Weeks of TreatmentSVR in both study arms
Measured: 72 Weeks from initiation of treatment
Number of Participants Achieving Sustained Virological Response (SVR)
HCV RNA negativity at 24 weeks after completion of all study medications
Measured: 24 weeks after completion of all study medications
Secondary outcomes (3)
A Comparison of the Percentage of Participants With Non-detectable HCV-RNA After 24 Weeks of Therapy.
A comparison of the proportion of the subject population with non-detectable HCV-RNA after 24 wks of therapy.
Measured: 24 weeks
Percentage of Participants Experiencing Serious Adverse Events
The severity of adverse events was graded according to modified World Health Organization grades as mild, moderate, severe, or life-threatening
Measured: 72 Weeks from initiation of treatment
Percentage of Participants Experiencing Medically Significant Infections
Medically significant infection was defined as an infection requiring the use of intravenous antibiotics or hospitalization.
Measured: 72 weeks from initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nizar Zein
- Sponsor type
- University, hospital or other
- Collaborators
- Centocor, Inc.
- Responsible party
- Sponsor-investigator, Nizar Zein, The Cleveland Clinic
- Investigators
- Nizar N Zein, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512278
- Sponsor's protocol ID
- PARTNER
- Acronym
- PARTNER
- Status last verified
- Aug 2017
- First submitted
- 3 Aug 2007
- Last updated
- 13 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infliximab (Remicade®) as an Adjunct to Pegylated- Interferon α-2b and Ribavirin in the Treatment of Hepatitis C Virus Infection
- ClinicalTrials.gov ID
- NCT00512278
- Acronym / sponsor ID
- PARTNER / PARTNER
- Conditions
- Hepatitis C
- Keywords
- Hepatitis, HCV, Hepatitis C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Nizar ZeinUniversity, hospital or other
- Collaborators
- Centocor, Inc.
- Study start
- Jul 2007
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 7 Aug 2007 (estimated)
- Results
- Posted 13 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate in subjects receiving their first course of peg-interferon α-2b plus ribavirin therapy for chronic HCV infection
Detailed description
The aim of the study is to investigate in subjects receiving their first course of peg-interferon α-2b plus ribavirin therapy for chronic HCV infection (genotype 1) whether the addition of infliximab to a standard regimen of pegylated interferon α-2b in combination with ribavirin:
- increases the proportion of subjects attaining a sustained virological response SVR (undetectable blood Hepatitis C viral load 6 months after treatment)
- improves the safety profile compared to the same regimen without infliximab
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infliximab | Experimental | Drug: InfliximabInfliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Male or female subjects, >18 years of age with proven chronic (greater than 6 months) hepatitis C infection (genotype 1) who have never been treated with pegylated interferon α-2b and /or ribavirin.
- Male or female, 18 years of age or older
- Positive HCV RNA, Genotype 1, treatment naïve (never received pegylated interferon and / or ribavirin)
- Evidence of chronic HCV infection for at least six months prior to screening
- Findings on liver biopsy within the past 36 months that are consistent with the presence of chronic hepatitis C infection.
Key exclusion criteria (18 listed)
- Women who are pregnant, nursing, or planning pregnancy within 6 months after the last infusion and men with partners who are pregnant at baseline or intend to become pregnant within 6 months after the last infusion.
- Known allergy against infliximab, ribavirin, or pegylated interferon
- Decompensated liver disease characterized as decreased hepatic synthetic functioning with abnormal albumin and bilirubin levels, prolonged prothrombin time or complications including ascites or recent variceal bleeding
- have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidiomycosis (Valley Fever)
- History of autoimmune hepatitis or a history of poorly controlled autoimmune disease
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 |
|---|---|---|
| InfliximabAlso: RemicadeInfliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46 | Drug | Infliximab |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
A Comparison of the Percentage of Chronic Hepatitis C Subjects (Treatment Naive,Genotype 1) Who Achieve SVR at Week 72, After 48 Weeks of Treatment.
Time frame: 72 Weeks from initiation of treatment
A comparison of the Proportion of Chronic Hepatitis C Subjects (Treatment Naive,Genotype 1) Who Achieve SVR at Week 72, After 48 Weeks of TreatmentSVR in both study arms
Number of Participants Achieving Sustained Virological Response (SVR)
Time frame: 24 weeks after completion of all study medications
HCV RNA negativity at 24 weeks after completion of all study medications
3 secondary outcomes
A Comparison of the Percentage of Participants With Non-detectable HCV-RNA After 24 Weeks of Therapy.
Time frame: 24 weeks
Percentage of Participants Experiencing Serious Adverse Events
Time frame: 72 Weeks from initiation of treatment
Percentage of Participants Experiencing Medically Significant Infections
Time frame: 72 weeks from initiation of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Hepatitis B
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A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
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.
Nizar N Zein, MD principal investigator
The Cleveland Clinic
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Infliximab in people with Hepatitis C, run by Nizar Zein at 7 sites in United States.
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 18 inclusion and 18 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 13 Sep 2017. 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 United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
A Comparison of the Percentage of Chronic Hepatitis C Subjects (Treatment Naive,Genotype 1) Who Achieve SVR at Week 72, After 48 Weeks of Treatment. (time frame: 72 Weeks from initiation of treatment). The study lists 2 primary outcomes in all. 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 Sep 2017; AzTrials last refreshed its copy on 8 Nov 2026.