Hepatitis CREACHSVRNCT00951223
Observational Prospective Registry of the Efficacy, Safety, and Adherence to Infergen® in Patients Infected With Hep C
An observational study of Hepatitis C, run by Kadmon Corporation, LLC.
Trial summary
This observational prospective registry is designed to evaluate the safety, adherence, and efficacy of prescribed, patient-administered therapy with Infergen® (Interferon alfacon 1) and other prescribed therapies in patients chronically infected with HCV. 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?
- Infergen® (Interferon alfacon-1)
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Apr 2011
- Phase
- Observational
- 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
Study population: Patients from Community Gastrointestinal Practices as well as Academic Centers will be asked to participate
Who may be able to join
- Willing to consent to data being collected and provided to the Duke Clinical Research Institute (DCRI) and Three Rivers Pharmaceuticals
- Able and willing to give written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization, and to comply with the requirements of the registry protocol
- Anti-HCV antibody-positive
- HCV RNA concentration >100,000 IU/mL on reverse transcriptase-polymerase chain reaction (RT-PCR) assay at baseline or >90 days before the baseline visit
- Deemed by the investigator to be an appropriate patient for treatment with Infergen and other prescribed medications
- Baseline CD4 count >200 cells/mm3 (human immunodeficiency virus [HIV]-HCV coinfected patients)
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- Women: must be documented to be surgically sterile, be postmenopausal (defined as >2 years without menses), or agree to use 2 forms of effective contraception during the registry and for 6 months after receiving the final dose of study drug. Men: must agree to use 2 forms of effective contraception during the registry and for 6 months after receiving the final dose of study drug, and their partners of childbearing potential must not be pregnant at screening.
- Women: must not be lactating and, if of childbearing potential, must have a negative serum pregnancy test result at the baseline visit
- Age >18 years
Who cannot join
- Unable to complete all clinic visits and comply with registry procedures, including self-injection of Infergen
- Known hypersensitivity to alpha-interferons or any component of the product
- Decompensated hepatic disease
- Autoimmune hepatitis
- Hemoglobinopathies (i.e., thalassemia or sickle cell anemia)
- Any other condition that, in the opinion of the investigator, would make the patient unsuitable for enrollment or could interfere with the patient participating in and completing the registry
About this study
Official title: Observational Prospective Registry of the Efficacy, Safety, and Adherence to Therapy of Infergen® (Interferon Alfacon 1) in Patients Chronically Infected With Hepatitis C Virus
This observational prospective registry is designed to evaluate the safety, adherence, and efficacy of prescribed, patient-administered therapy with Infergen® (Interferon alfacon 1) and other prescribed therapies in patients chronically infected with HCV. The primary endpoint for efficacy will be the SVR rate at 24 weeks after therapy ends.
Read the detailed description
This registry plans to enroll 1000 patients at 75 clinical sites across the United States.
Potentially eligible patients will be anti-HCV antibody-positive and have detectable serum or plasma HCV RNA. Patients can have any HCV genotype; they also can be antiviral treatment-naïve or have a history of either nonresponse or relapse to previous antiviral therapy. Patients can roll over directly from current interferon (IFN) therapy into registry Infergen therapy, but the average washout period will be <1 month. Rollovers will occur after 4, 12, or 24 weeks of IFN therapy. Patients coinfected with HBV or HIV can be included in the registry.
Each investigator participating in this registry will employ his or her discretion and standard clinical practice to determine when to see the patient in the clinic, how to manage the patient's drug regimen, and how best to monitor the patient's response and tolerance to therapy.The decision to enroll a patient and start therapy with Infergen and other prescribed therapies may be guided by historic biopsy results, or the patient can undergo liver biopsy at the investigator's discretion. Biopsy is not a prerequisite, however, if the investigator believes it to be unnecessary. When a patient's treatment is expected to require significant dose modification and/or more intensive monitoring because of comorbid conditions, enrolling the patient in the registry is at the investigator's discretion. For purposes of the registry, data will be collected at baseline; at Weeks 4, 12, 24, and 48 from the start of therapy; and at follow-up visits 4 and 24 weeks after treatment ends.
Safety will be assessed by monitoring AEs, reduction/discontinuation of therapy because of AEs, routine laboratory results and by other means determined by the investigator. Adherence over the course of therapy will also be evaluated, taking into account physician-directed dose reduction or cessation, patients' self-reports of compliance, and the return of used and unused medication to each scheduled visit.
- Conditions
- Hepatitis C
- Being tested
- Infergen® (Interferon alfacon-1)
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infergen® (Interferon alfacon-1)Drug
Also called INF
Infergen at either the 15 mcg or 9 mcg dose given per Providers instructions, with or without weight based ribavirin
| Study group | Role | What they receive |
|---|---|---|
| Patients with Chronic Hepatitis C | HCV positive patients who have failed previous HCV therapy This observational prospective registry is designed to evaluate the safety, adherence, and efficacy of prescribed, patientadministered therapy with Infergen® (Interferon alfacon-1) and other prescribed therapies in patients chronically infected with HCV. The primary endpoint for efficacy will be the SVR rate at 24 weeks after therapy ends. Safety will be assessed by monitoring AEs, reduction/discontinuation of therapy because of AEs, routine laboratory results and by other means determined by the Investigator Receives: Drug: Infergen® (Interferon alfacon-1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the incidence of SVR, defined as undetectable HCV RNA measured 24 weeks after therapy ends, associated with prescribed, patient-administered therapy with Infergen® (Interferon alfacon 1) in patients chronically infected with HCV.
Measured: 24 weeks post end of therapy
Secondary outcomes (1)
Capture of defined adverse events (AEs),dose changes or cessation, and adherence to the prescribed dose of Infergen and other prescribed therapies over the course of treatment
Measured: Treatment weeks 4, 12, 24, 48, and Follow-Up weeks 4 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionNov 2010
- Study completionApr 2011
Why it stopped: Lack of Enrollment
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kadmon Corporation, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Muir, MD, Principal investigator, DCRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951223
- Sponsor's protocol ID
- CIFN 003
- Acronym
- REACHSVR
- Status last verified
- Sep 2015
- First submitted
- 3 Aug 2009
- Last updated
- 3 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Prospective Registry of the Efficacy, Safety, and Adherence to Therapy of Infergen® (Interferon Alfacon 1) in Patients Chronically Infected With Hepatitis C Virus
- ClinicalTrials.gov ID
- NCT00951223
- Acronym / sponsor ID
- REACHSVR / CIFN 003
- Conditions
- Hepatitis C
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of Enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kadmon Corporation, LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 4 Aug 2009 (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.
This observational prospective registry is designed to evaluate the safety, adherence, and efficacy of prescribed, patient-administered therapy with Infergen® (Interferon alfacon 1) and other prescribed therapies in patients chronically infected with HCV. The primary endpoint for efficacy will be the SVR rate at 24 weeks after therapy ends.
Detailed description
This registry plans to enroll 1000 patients at 75 clinical sites across the United States.
Potentially eligible patients will be anti-HCV antibody-positive and have detectable serum or plasma HCV RNA. Patients can have any HCV genotype; they also can be antiviral treatment-naïve or have a history of either nonresponse or relapse to previous antiviral therapy. Patients can roll over directly from current interferon (IFN) therapy into registry Infergen therapy, but the average washout period will be <1 month. Rollovers will occur after 4, 12, or 24 weeks of IFN therapy. Patients coinfected with HBV or HIV can be included in the registry.
Each investigator participating in this registry will employ his or her discretion and standard clinical practice to determine when to see the patient in the clinic, how to manage the patient's drug regimen, and how best to monitor the patient's response and tolerance to therapy.The decision to enroll a patient and start therapy with Infergen and other prescribed therapies may be guided by historic biopsy results, or the patient can undergo liver biopsy at the investigator's discretion. Biopsy is not a prerequisite, however, if the investigator believes it to be unnecessary. When a patient's treatment is expected to require significant dose modification and/or more intensive monitoring because of comorbid conditions, enrolling the patient in the registry is at the investigator's discretion. For purposes of the registry, data will be collected at baseline; at Weeks 4, 12, 24, and 48 from the start of therapy; and at follow-up visits 4 and 24 weeks after treatment ends.
Safety will be assessed by monitoring AEs, reduction/discontinuation of therapy because of AEs, routine laboratory results and by other means determined by the investigator. Adherence over the course of therapy will also be evaluated, taking into account physician-directed dose reduction or cessation, patients' self-reports of compliance, and the return of used and unused medication to each scheduled visit.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Chronic Hepatitis C | – | Drug: Infergen® (Interferon alfacon-1)HCV positive patients who have failed previous HCV therapy This observational prospective registry is designed to evaluate the safety, adherence, and efficacy of prescribed, patientadministered therapy with Infergen® (Interferon alfacon-1) and other prescribed therapies in patients chronically infected with HCV. The primary endpoint for efficacy will be the SVR rate at 24 weeks after therapy ends. Safety will be assessed by monitoring AEs, reduction/discontinuation of therapy because of AEs, routine laboratory results and by other means determined by the Investigator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from Community Gastrointestinal Practices as well as Academic Centers will be asked to participate
Key inclusion criteria (9 listed)
- Willing to consent to data being collected and provided to the Duke Clinical Research Institute (DCRI) and Three Rivers Pharmaceuticals
- Able and willing to give written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization, and to comply with the requirements of the registry protocol
- Anti-HCV antibody-positive
- HCV RNA concentration >100,000 IU/mL on reverse transcriptase-polymerase chain reaction (RT-PCR) assay at baseline or >90 days before the baseline visit
- Deemed by the investigator to be an appropriate patient for treatment with Infergen and other prescribed medications
Key exclusion criteria (6 listed)
- Unable to complete all clinic visits and comply with registry procedures, including self-injection of Infergen
- Known hypersensitivity to alpha-interferons or any component of the product
- Decompensated hepatic disease
- Autoimmune hepatitis
- Hemoglobinopathies (i.e., thalassemia or sickle cell anemia)
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 |
|---|---|---|
| Infergen® (Interferon alfacon-1)Also: INFInfergen at either the 15 mcg or 9 mcg dose given per Providers instructions, with or without weight based ribavirin | Drug | Patients with Chronic Hepatitis C |
Primary outcome
Determine the incidence of SVR, defined as undetectable HCV RNA measured 24 weeks after therapy ends, associated with prescribed, patient-administered therapy with Infergen® (Interferon alfacon 1) in patients chronically infected with HCV.
Time frame: 24 weeks post end of therapy
1 secondary outcome
Capture of defined adverse events (AEs),dose changes or cessation, and adherence to the prescribed dose of Infergen and other prescribed therapies over the course of treatment
Time frame: Treatment weeks 4, 12, 24, 48, and Follow-Up weeks 4 and 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2015.
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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.
Andrew Muir, MD principal investigator
DCRI
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Kadmon Corporation, LLC.
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 9 inclusion and 6 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: withdrawn, as of the sponsor's last update on 3 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Determine the incidence of SVR, defined as undetectable HCV RNA measured 24 weeks after therapy ends, associated with prescribed, patient-administered therapy with Infergen® (Interferon alfacon 1) in patients chronically infected with HCV. (time frame: 24 weeks post end of therapy). 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 3 Sep 2015.