Chronic Hepatitis C Virus InfectionPhase 3NCT00215865
PEG-Interferon a-2b + Ribavirin for Treatment of Patients With Chronic Hepatitis C Who Have Previously Failed to Achieve a Sustained Virologic Response Following Interferon Alfa or Interferon a-2b + Ribavirin Therapy
A Phase 3 study testing PEGIntron plus ribavirin in people with Chronic Hepatitis C Virus Infection, run by Hepatitis Resource Network at 1 site in United States.
Trial summary
HRN-003 STUDY SYNOPSIS OBJECTIVE: To compare the Sustained Virologic Response (SVR) of PEGIntron plus ribavirin among patients receiving a fixed dose of PEGIntron versus weighted-adjusted dosing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C Virus Infection
- What is being tested?
- PEGIntron plus ribavirin
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must meet the following criteria for entry:
- 5.1.1 Adult male or female, age of 18 or older.
- 5.1.2 Serums positive for hepatitis C virus by RT-PCR or other assay (bDNA).
- 5.1.3 HCV genotype result must be available at screening.
- 5.1.4 Previous antiviral therapy with interferon or interferon plus ribavirin for at least 12 weeks with the failure to obtain a sustained virologic response.
- 5.1.5 No therapy with interferon alfa or interferon alfa-2b plus ribavirin or other specific anti-HCV medications within 6 weeks of the Entry visit.
Show all 24Show fewer
- 5.1.6 Compensated liver disease with the following laboratory parameters at the Entry visit:
- Hemoglobin values of ³ 12 gm/dL for females or ³ 13 gm/dL for males
- WBC ³ 3,000/mm3
- Neutrophil count ³1,500/mm3
- Platelets ³ 70,000/mm3
- Prothrombin time < 2 seconds prolonged compared to control, or equivalent INR ratio
- Bilirubin within 20% of the upper limit of normal (unless non-hepatitis related factors such as Gilbert's disease explains an indirect bilirubin rise).
- Albumin > 3.0 g/dL (or within 20% of LLN)
- Serum creatinine < 1.4 mg/dL
- Hemoglobin A1C < 8.5% for diabetic patients (whether on medication and/or diet controlled)
- Thyroid Stimulating Hormone (TSH) within normal limits or thyroid disease under clinical control
- 5.1.7 Alpha-fetoprotein (AFP) value within normal limits obtained within the prior year. For patients with results above the upper limit of normal but < 50 ng/mL both of the following are required:
- Alpha-fetoprotein value < 50 ng/mL obtained within 3 months prior to entry AND
- Ultrasound obtained within 3 months prior to entry that is negative for evidence of hepatocellular carcinoma.
- 5.1.8 Reconfirmation and documentation that all sexually active female patients of childbearing potential are practicing adequate contraception (intrauterine device, oral contraceptives, progesterone implanted rods [Norplant], medroxyprogesterone acetate [Depo-Provera], surgical sterilization, barrier method [diaphragm + spermicide], or monogamous relationship with a male partner who has had a vasectomy or is using a condom + spermicide) during the treatment period and for 6 months after discontinuation of therapy. A urine pregnancy test obtained at entry prior to the initiation of treatment must be negative. Female patients must not be breast feeding. Documentation that sexually active male patients are practicing acceptable methods of contraception (vasectomy, use of a condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 6 months after discontinuation of therapy.
- 5.1.9 Anyone at high risk of coronary artery disease should have a stress test performed prior to entry. This would include, but not be limited to, patients over age 55 who have a history of ischemia or who have a significant history of hypertension, diabetes mellitus, obesity, smoking and/or strong family history of coronary artery disease. Patients with evidence of ischemia on resting or stress EKG, or a history of an arrhythmia, angina or a myocardial infarction within 12 months must be excluded.
- 5.1.10 Liver biopsy is not required for study entry. However, if a liver biopsy has been obtained, within three years of the initial screening visit, the pathology report will be collected with other study data.
- 5.1.11 Written informed consent specific for this protocol has been obtained prior to entry.
Who cannot join
- The patient will be excluded from entry if any of the following criteria apply:
- 5.2.1 Hypersensitivity to alpha interferon or ribavirin.
- 5.2.2 Any other causes for chronic liver disease other than chronic hepatitis C.
- 5.2.3 Hemoglobinopathies (e.g., Thalassemia) or any other cause of hemolytic anemia.
- 5.2.4 Evidence of advanced liver disease such as a history of or presence of ascites, bleeding varices, or spontaneous encephalopathy.
- 5.2.5 Any known preexisting medical condition that could interfere with the patient s participation in the protocol including: CNS trauma or active seizure disorders requiring medication; poorly controlled diabetes mellitus; serious pulmonary disease; immunologically-mediated diseases; gout; or any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids.
Show all 15Show fewer
- 5.2.6 Patients with evidence of ischemia on stress testing (required for patients at risk of or with a history of coronary artery disease), ECG evidence of ischemia, an arrhythmia, cardiac failure, coronary surgery, uncontrolled hypertension, angina or a myocardial infarction within 12 months.
- 5.2.7 Patients with clinically significant retinal abnormalities.
- 5.2.8 Substance abuse, such as alcohol (> 80 gm/day), I.V. drugs and inhaled drugs. If the patient has a history of substance abuse, to be considered for inclusion into the protocol, the patient must have abstained from using the abused substance for at least 1 year. Patients receiving methadone within the past year are eligible if they undergo a program of testing for substance abuse at study entry and then randomly at least every three months during therapy. Persons withdrawn from methadone therapy due to violations within their methadone program will be ineligible.
- 5.2.9 Patients with an alcohol consumption of > 20 gm/day are ineligible for the protocol. Patients must be counseled with regard to the need to abstain from the consumption of alcohol.
- 5.2.10 Concurrent use of nucleoside analogs, amantadine/rimantadine, and HIV protease inhibitors will be excluded.
- 5.2.11 Patients with a history of organ transplantation will be excluded.
- 5.2.12 Preexisting psychiatric conditions; especially depression, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or suicidal attempt are excluded. Patients with a history of mild depression may enter the protocol if they meet the following eligibility criterion and are monitored as outlined in Section 11.2 (Management of Depression During Study).
- Mild depression: to include either situational depression of a limited period or depressive symptoms, which do not significantly interfere with the patients work or daily functions. Any patient with a manic element to his/her previous symptom complex will be excluded.
- Detailed follow-up of each patient may be individualized according to his/her need; this would usually include further predetermined visits. Patients with a history of mild depression or patients undergoing successful treatment for mild depression will be managed as outlined in Section 11.2 (Management of Depression During Study).
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Univesity School of Medicine
Baltimore, Maryland, 21287
About this study
Official title: HRN 003PEG-Interferon a-2b + Ribavirin for Treatment of Patients With Chronic Hepatitis C Who Have Previously Failed to Achieve a Sustained Virologic Response Following Interferon Alfa or Interferon a-2b + Ribavirin Therapy
HRN-003 STUDY SYNOPSIS
OBJECTIVE: To compare the Sustained Virologic Response (SVR) of PEGIntron plus ribavirin among patients receiving a fixed dose of PEGIntron versus weighted-adjusted dosing.
Read more
OVERVIEW OF STUDY DESIGN: This is a multi-center, randomized, open-label clinical trial using PEGIntron weight-adjusted dose by subcutaneous injection weekly + ribavirin by mouth twice daily for 48 weeks OR PEGIntron fixed dose by subcutaneous injection weekly + ribavirin by mouth twice daily for 48 weeks.
STUDY POPULATION: 600 Adult patients with chronic hepatitis C virus infection who have previously failed to achieve a sustained virologic response following interferon alfa or interferon alfa-2b plus ribavirin therapy.
DOSAGE AND ADMINISTRATION: Eligible participants will be randomized to receive PEGIntron weight-adjusted dose (1.5 mg/kg) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks OR PEGIntron fixed dose (150 mg if weight > than 80 kg or 100 mg if weight < 80 KG) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks.
EFFICACY EVALUATIONS: Laboratory analysis, quality of life assessments, and change in study medication doses will be obtained.
SAFETY EVALUATIONS: Assessment of laboratory evaluations, vital signs, incidence and severity of adverse experiences and progression of disease, as measured by HCV viral load.
STUDY DESIGN
This is a treatment protocol to evaluate the antiviral efficacy, safety and tolerability polyethylene glycol (PEG) conjugated interferon alfa-2b (PEGIntron) for the treatment of chronic hepatitis C virus infection in patients who have previously failed to achieve a sustained virologic response following interferon alfa or interferon alfa-2b plus ribavirin therapy. Patients will be stratified according to their response to the previous course of therapy (i.e. non-reponse or relapse virologic pattern
This is a multi-center, randomized, open-label clinical trial that will involve approximately 25 sites with an anticipated enrollment of 600 patients over a six-month period.
Eligible participants will be randomized to receive PEGIntron weight-adjusted dose (1.5 mg/kg) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks OR PEGIntron fixed dose (150 mg if weight > than 80 kg or 100 mg if weight < 80 KG) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks.
- Group A: PEGIntron weight -adjusted dose (1.5 mg/kg) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks (Total therapy x 48weeks).
- Group B: PEGIntron fixed dose (150 mg if weight > than 80 kg or 100 mg if weight < 80 KG) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for an additional 48 weeks (Total therapy x 48 weeks).
- Conditions
- Chronic Hepatitis C Virus Infection
- Being tested
- PEGIntron plus ribavirin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEGIntron plus ribavirinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
1. To compare the Sustained Virologic Response (SVR) of PEGIntron plus ribavirin among patients receiving a fixed dose of PEGIntron versus weighted-adjusted dosing
Secondary outcomes (2)
2. To evaluate the safety and tolerability PEG Intron in combination with ribavirin given as a fixed dose versus weight adjusted.
3. To determine the Early Virologic Response (EVR) at week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis C Virus InfectionStudies 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
- 600 participants
Sponsor and investigators
- Lead sponsor
- Hepatitis Resource Network
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Investigators
- Mark Sulkowski, MD, Principal investigator, Hepatitis Resource Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215865
- Sponsor's protocol ID
- HRN 003
- Status last verified
- Sep 2005
- First submitted
- 20 Sep 2005
- Last updated
- 22 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HRN 003PEG-Interferon a-2b + Ribavirin for Treatment of Patients With Chronic Hepatitis C Who Have Previously Failed to Achieve a Sustained Virologic Response Following Interferon Alfa or Interferon a-2b + Ribavirin Therapy
- ClinicalTrials.gov ID
- NCT00215865
- Acronym / sponsor ID
- HRN 003
- Conditions
- Chronic Hepatitis C Virus Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- Hepatitis Resource NetworkUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- First posted
- 22 Sep 2005 (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.
HRN-003 STUDY SYNOPSIS
OBJECTIVE: To compare the Sustained Virologic Response (SVR) of PEGIntron plus ribavirin among patients receiving a fixed dose of PEGIntron versus weighted-adjusted dosing.
OVERVIEW OF STUDY DESIGN: This is a multi-center, randomized, open-label clinical trial using PEGIntron weight-adjusted dose by subcutaneous injection weekly + ribavirin by mouth twice daily for 48 weeks OR PEGIntron fixed dose by subcutaneous injection weekly + ribavirin by mouth twice daily for 48 weeks.
STUDY POPULATION: 600 Adult patients with chronic hepatitis C virus infection who have previously failed to achieve a sustained virologic response following interferon alfa or interferon alfa-2b plus ribavirin therapy.
DOSAGE AND ADMINISTRATION: Eligible participants will be randomized to receive PEGIntron weight-adjusted dose (1.5 mg/kg) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks OR PEGIntron fixed dose (150 mg if weight > than 80 kg or 100 mg if weight < 80 KG) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks.
EFFICACY EVALUATIONS: Laboratory analysis, quality of life assessments, and change in study medication doses will be obtained.
SAFETY EVALUATIONS: Assessment of laboratory evaluations, vital signs, incidence and severity of adverse experiences and progression of disease, as measured by HCV viral load.
STUDY DESIGN
This is a treatment protocol to evaluate the antiviral efficacy, safety and tolerability polyethylene glycol (PEG) conjugated interferon alfa-2b (PEGIntron) for the treatment of chronic hepatitis C virus infection in patients who have previously failed to achieve a sustained virologic response following interferon alfa or interferon alfa-2b plus ribavirin therapy. Patients will be stratified according to their response to the previous course of therapy (i.e. non-reponse or relapse virologic pattern
This is a multi-center, randomized, open-label clinical trial that will involve approximately 25 sites with an anticipated enrollment of 600 patients over a six-month period.
Eligible participants will be randomized to receive PEGIntron weight-adjusted dose (1.5 mg/kg) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks OR PEGIntron fixed dose (150 mg if weight > than 80 kg or 100 mg if weight < 80 KG) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks.
- Group A: PEGIntron weight -adjusted dose (1.5 mg/kg) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks (Total therapy x 48weeks).
- Group B: PEGIntron fixed dose (150 mg if weight > than 80 kg or 100 mg if weight < 80 KG) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for an additional 48 weeks (Total therapy x 48 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 5.1.1 Adult male or female, age of 18 or older.
- 5.1.2 Serums positive for hepatitis C virus by RT-PCR or other assay (bDNA).
- 5.1.3 HCV genotype result must be available at screening.
- 5.1.4 Previous antiviral therapy with interferon or interferon plus ribavirin for at least 12 weeks with the failure to obtain a sustained virologic response.
- 5.1.5 No therapy with interferon alfa or interferon alfa-2b plus ribavirin or other specific anti-HCV medications within 6 weeks of the Entry visit.
Key exclusion criteria (15 listed)
- 5.2.1 Hypersensitivity to alpha interferon or ribavirin.
- 5.2.2 Any other causes for chronic liver disease other than chronic hepatitis C.
- 5.2.3 Hemoglobinopathies (e.g., Thalassemia) or any other cause of hemolytic anemia.
- 5.2.4 Evidence of advanced liver disease such as a history of or presence of ascites, bleeding varices, or spontaneous encephalopathy.
- 5.2.5 Any known preexisting medical condition that could interfere with the patient s participation in the protocol including: CNS trauma or active seizure disorders requiring medication; poorly controlled diabetes mellitus; serious pulmonary disease; immunologically-mediated diseases; gout; or any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids.
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 |
|---|---|---|
| PEGIntron plus ribavirin | Drug | – |
Primary outcome
1. To compare the Sustained Virologic Response (SVR) of PEGIntron plus ribavirin among patients receiving a fixed dose of PEGIntron versus weighted-adjusted dosing
2 secondary outcomes
2. To evaluate the safety and tolerability PEG Intron in combination with ribavirin given as a fixed dose versus weight adjusted.
3. To determine the Early Virologic Response (EVR) at week 24.
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 22 Sep 2005.
Related trials for Chronic Hepatitis C Virus Infection
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.
Mark Sulkowski, MD principal investigator
Hepatitis Resource Network
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 PEGIntron plus ribavirin in people with Chronic Hepatitis C Virus Infection, run by Hepatitis Resource Network at 1 site 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 24 inclusion and 15 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 22 Sep 2005. 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 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. 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?
1. To compare the Sustained Virologic Response (SVR) of PEGIntron plus ribavirin among patients receiving a fixed dose of PEGIntron versus weighted-adjusted dosing. 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 22 Sep 2005.