Hepatitis C, ChronicPhase 4NCT00087633

PHOENIX Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) Administered After Liver Transplantation for Hepatitis C.

A Phase 4 study testing peginterferon alfa-2a [Pegasys] and Copegus in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 28 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This 2-arm study was designed to evaluate the efficacy, safety, and tolerability of prophylactic PEGASYS plus COPEGUS after liver transplantation for hepatitis C, compared to initiation of antiviral therapy at the time of clinical recurrence of hepatitis C infection. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C, Chronic
What is being tested?: peginterferon alfa-2a [Pegasys] and Copegus
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 115 participants
Where: 28 sitesUnited States
Study dates: Oct 2004to Oct 2008
Phase: Phase 4
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

Adult patients at least 18 years of age
Positive hepatitis C virus RNA at pre-transplantation
Primary, single-organ recipient (cadaveric donor)
Liver transplant between 10 and 16 weeks before treatment initiation

Who cannot join

Multi-organ or re-transplant recipient
Evidence of current hepatitis B infection
Seropositive for human immunodeficiency (HIV) infection

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

United States28 sites

Study site
Aurora, Colorado, 80045
Study site
Baltimore, Maryland, 21205
Study site
Birmingham, Alabama, 35294
Study site
Burlington, Massachusetts, 01805
Study site
Chicago, Illinois, 60611
Study site
Cincinnati, Ohio, 45267
Study site
Dallas, Texas, 75246
Study site
Gainesville, Florida, 32610-0214
Study site
Indianapolis, Indiana, 46202
Study site
Jacksonville, Florida, 32216
Study site
Los Angeles, California, 90095-1749
Study site
Madison, Wisconsin, 53792
Study site
Miami, Florida, 33136-1051
Study site
Minneapolis, Minnesota, 55455
Study site
Nashville, Tennessee, 37232
Study site
New York, New York, 10016
Study site
New York, New York, 10029
Study site
Newark, New Jersey, 07101-1709
Study site
Omaha, Nebraska, 68198-3285
Study site
Philadelphia, Pennsylvania, 19104
Study site
Philadelphia, Pennsylvania, 19141
Study site
Phoenix, Arizona, 85054
Study site
Rochester, Minnesota, 55905
Study site
San Antonio, Texas, 78284
Study site
San Francisco, California, 94115
Study site
San Francisco, California, 94143
Study site
Seattle, Washington, 98195
Study site
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Randomized, Open-label Study of Prophylactic Administration of PEGASYS Plus Ribavirin After Liver Transplantation on Hepatitis C Recurrence in Patients With Hepatitis C

Conditions: Hepatitis C, Chronic
Being tested: peginterferon alfa-2a [Pegasys], Copegus
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.

peginterferon alfa-2a [Pegasys]Drug
135 micrograms subcutaneously (SC) weekly for 4 weeks followed by 180 micrograms SC weekly for 44 weeks
CopegusDrug
400 mg orally (PO) daily escalating to 1200 mg PO daily, for 48 weeks

Study groups in NCT00087633
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: peginterferon alfa-2a [Pegasys]; Drug: Copegus
2	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Patients With Histologically-confirmed Recurrence of Hepatitis C Virus (HCV)
Histologically-confirmed recurrence of HCV defined as Batts-Ludwig inflammation grade ≥3 and/or fibrosis stage ≥2.
Inflammation(Grade): 0 No Activity,1 Minimal,2 Mild,3 Moderate,4 Severe.
Fibrosis (Stage): 0 No fibrosis, Normal; 1 Portal fibrosis; 2 Periportal fibrosis or rare portal septa; 3 Septal fibrosis, Fibrous septa with architectural distortion, no obvious cirrhosis; 4 Cirrhosis.
Measured: 120 weeks postrandomization

Secondary outcomes (1)

Summary of Virologic Response
Rapid virologic responder (RVR): undetectable HCV-RNA at Week 4; complete early virologic responder (cEVR): undetectable HCV-RNA at Week 12; partial early virologic responder (pEVR): ≥2 log10 drop from baseline in HCV-RNA but positive at Week 12; early virologic responder (EVR): undetectable HCV-RNA or ≥2 log10 drop from baseline in HCV-RNA at Week 12; 24 weeks negative: undetectable HCV-RNA at Week 24; 48 weeks negative: undetectable HCV-RNA at Week 48; sustained virologic response (SVR): undetectable HCV-RNA at 24 weeks after the end of treatment.
Measured: After 4, 12, 24 and 48 weeks of therapy, and 24 weeks of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2004Oct 2008

First posted14 Jul 2004 (estimated)
Study startOct 2004
Primary completionOct 2008
Study completionOct 2008

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 115 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00087633
Sponsor's protocol ID: ML18124
Status last verified: Feb 2018
First submitted: 12 Jul 2004
Last updated: 29 Mar 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

Bzowej N, Nelson DR, Terrault NA, Everson GT, Teng LL, Prabhakar A, Charlton MR; PHOENIX Study Group. PHOENIX: A randomized controlled trial of peginterferon alfa-2a plus ribavirin as a prophylactic treatment after liver transplantation for hepatitis C virus. Liver Transpl. 2011 May;17(5):528-38. doi: 10.1002/lt.22271.
PubMed 21506241

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label Study of Prophylactic Administration of PEGASYS Plus Ribavirin After Liver Transplantation on Hepatitis C Recurrence in Patients With Hepatitis C
ClinicalTrials.gov ID: NCT00087633
Acronym / sponsor ID: ML18124
Conditions: Hepatitis C, Chronic
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 115 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Oct 2004
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 14 Jul 2004 (estimated)
Results: Posted 24 Jan 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: peginterferon alfa-2a [Pegasys], Drug: Copegus
2	No intervention	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Adult patients at least 18 years of age
Positive hepatitis C virus RNA at pre-transplantation
Primary, single-organ recipient (cadaveric donor)
Liver transplant between 10 and 16 weeks before treatment initiation

Key exclusion criteria (3 listed)

Multi-organ or re-transplant recipient
Evidence of current hepatitis B infection
Seropositive for human immunodeficiency (HIV) 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
peginterferon alfa-2a [Pegasys]135 micrograms subcutaneously (SC) weekly for 4 weeks followed by 180 micrograms SC weekly for 44 weeks	Drug	1
Copegus400 mg orally (PO) daily escalating to 1200 mg PO daily, for 48 weeks	Drug	1

Primary outcome

Percentage of Patients With Histologically-confirmed Recurrence of Hepatitis C Virus (HCV)
Time frame: 120 weeks postrandomization
Histologically-confirmed recurrence of HCV defined as Batts-Ludwig inflammation grade ≥3 and/or fibrosis stage ≥2. Inflammation(Grade): 0 No Activity,1 Minimal,2 Mild,3 Moderate,4 Severe. Fibrosis (Stage): 0 No fibrosis, Normal; 1 Portal fibrosis; 2 Periportal fibrosis or rare portal septa; 3 Septal fibrosis, Fibrous septa with architectural distortion, no obvious cirrhosis; 4 Cirrhosis.

1 secondary outcome

Summary of Virologic Response
Time frame: After 4, 12, 24 and 48 weeks of therapy, and 24 weeks of follow-up

Results and safety

Results posted to the registry on 24 Jan 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prophylaxis Arm	55	31
Observation Arm	60	43

Primary outcome: Percentage of Patients With Histologically-confirmed Recurrence of Hepatitis C Virus (HCV)

Time frame: 120 weeks postrandomization. Number. Unit: percentage of participants

Measure	Prophylaxis Arm n = 55	Observation Arm n = 60
Value	61.8	65.0

Prophylaxis Arm vs Observation Arm: Mean Difference (Final Values): -3.2 (95% CI -20.8 to 14.4), p = 0.725, Cochran-Mantel-Haenszel

Population analysed: Intent-to-treat population

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse Events were collected for the period of the study (4 years, 12-Oct-2004 - 17-Oct-2008). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prophylaxis Arm	25 of 54 (46.3%)	54 of 54 (100%)	Not reported
Observation Arm	21 of 60 (35%)	58 of 60 (96.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21506241Bzowej N, Nelson DR, Terrault NA, Everson GT, Teng LL, Prabhakar A, Charlton MR; PHOENIX Study Group. PHOENIX: A randomized controlled trial of peginterferon alfa-2a plus ribavirin as a prophylactic treatment after liver transplantation for hepatitis C virus. Liver Transpl. 2011 May;17(5):528-38. doi: 10.1002/lt.22271.

Related trials for Hepatitis C, Chronic

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.

Clinical Trials study director

Hoffmann-La Roche

28 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing peginterferon alfa-2a [Pegasys] and Copegus in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 28 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 4 inclusion and 3 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 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 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. 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?

Yes. Results are posted in the registry (first posted 24 Jan 2011). 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?

Percentage of Patients With Histologically-confirmed Recurrence of Hepatitis C Virus (HCV) (time frame: 120 weeks postrandomization). 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 NCT00087633, 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 29 Mar 2018.