Hepatitis C, ChronicPhase 4NCT00474955

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis C and Chronic Renal Failure.

A Phase 4 study testing peginterferon alfa-2a [Pegasys] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 5 sites in Russia.

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

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Hepatitis C, Chronic
What is being tested?: peginterferon alfa-2a [Pegasys]
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 5 sitesRussia
Study dates: Jul 2007to Jun 2011
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 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

adult patients, 18-60 years of age;
chronic hepatitis C;
chronic renal failure, including patients on hemodialysis therapy;
detectable HCV RNA levels (>500IU/mL).

Who cannot join

concurrent active hepatitis A or B;
history or evidence of a medical condition associated with chronic liver disease other than HCV;
history or other evidence of decompensated liver disease;
therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment <=6 months prior to study;
acute renal failure.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Russia5 sites

Study site
Chita, 672090
Study site
Irkutsk, 664047
Study site
Khabarovsk, 680009
Study site
Khabarovsk, 680022
Study site
Orenburg, 460040

Other trials in Russia

About this study

Official title: Multicenter Open-label Observation Program in Patients With Chronic Hepatitis C and With Chronic Renal Failure (CRF) Receiving Peginterferon Alpha-2a (40 kDa) Pegasys

This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis C and end-stage renal disease, including patients on hemodialysis. Patients will receive PEGASYS at a dose of 180 micrograms weekly; those with a calculated glomerular filtration rate of <15mL/min will receive a reduced dose of 135 micrograms weekly. Following 48 weeks of treatment there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Conditions: Hepatitis C, Chronic
Being tested: peginterferon alfa-2a [Pegasys]
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
180 micrograms or 135 micrograms sc weekly for 48 weeks

Study groups in NCT00474955
Study group	Role	What they receive
Peginterferon Alpha-2a	Experimental	Eligible participants will be administered peginterferon alpha-2a [Pegasys] (40 kilo Dalton), 180 micrograms as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated glomerular filtration rate of <15 milliliter /minute will be administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks. Receives: Drug: peginterferon alfa-2a [Pegasys]

What is being measured

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

Percentage of Participants Achieving Sustained Virologic Response at 24 Weeks Following Treatment Completion
Sustained virologic response is defined as undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels (<50 international units [IU]/mL) at 24 weeks following the completion of 48 weeks treatment period (Week 72).
Measured: At Week 72
Percentage of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid Level at Week 24 and Week 48
HCV RNA level less than 50 IU/mL was considered to be undetectable.
Measured: At Week 24 and Week 48
Percentage of Participants With At Least a 2log10 Drop in Hepatitis C Virus Ribonucleic Acid at Week 24 as Compared to Baseline
The table below shows the percentage of participants with at least 2log10 drop in HCV RNA level at Week 24 as compared to Baseline (Screening visit [Days -30 to -1]).
Measured: From Baseline (Days -30 to -1) and Week 24

Secondary outcomes (5)

Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect
Measured: Up to Week 72
Number of Participants Who Prematurely Withdrew From the Treatment Over a Period of 48 Weeks
Participants who prematurely withdrew from the treatment for the following reasons: personal reasons (not related to the study), adverse events, and drug unavailability, are presented.
Measured: Up to Week 48
Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
Marked abnormal laboratory parameters included serum glutamic pyruvic transaminase (SGPT), serum glutamic oxaloacetic transaminase (SGOT), gamma-glutamyl transpeptidase (GGTP), total bilirubin, alkaline phosphatase (ALP), ferritin and transferrin saturation. These laboratory parameters were evaluated at Baseline (Screening visit [Days -30 to -1]) and at various Visits (V): Week 0 (V1), Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7) and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10).
Measured: Up to Week 72
Mean Change From Baseline in Blood Pressure up to Week 72
Mean change from Baseline in diastolic blood pressure (DBP) and systolic blood pressure (SBP) was recorded at Baseline (Screening visit [Days -30 to -1]) and at various Visits (V): Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7) and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10).
Measured: From Baseline (Days -30 to -1) to Week 72
Mean Change From Baseline in Heart Rate up to Week 72
Mean change from baseline in heart rate was recorded at Baseline (Screening visit [Days -30 to -1]), and at various Visits (V): Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7), and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10).
Measured: From Baseline (Days -30 to -1) to Week 72

Timeline

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

Jul 2007Jun 2011

First posted17 May 2007 (estimated)
Study startJul 2007
Primary completionJun 2011
Study completionJun 2011

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 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00474955
Sponsor's protocol ID: ML20434
Status last verified: Jun 2016
First submitted: 16 May 2007
Last updated: 25 Jul 2016
Results posted: Yes, on ClinicalTrials.gov

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 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter Open-label Observation Program in Patients With Chronic Hepatitis C and With Chronic Renal Failure (CRF) Receiving Peginterferon Alpha-2a (40 kDa) Pegasys
ClinicalTrials.gov ID: NCT00474955
Acronym / sponsor ID: ML20434
Conditions: Hepatitis C, Chronic
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 17 May 2007 (estimated)
Results: Posted 25 Jul 2016

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Peginterferon Alpha-2a	Experimental	Drug: peginterferon alfa-2a [Pegasys]Eligible participants will be administered peginterferon alpha-2a [Pegasys] (40 kilo Dalton), 180 micrograms as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated glomerular filtration rate of <15 milliliter /minute will be administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

adult patients, 18-60 years of age;
chronic hepatitis C;
chronic renal failure, including patients on hemodialysis therapy;
detectable HCV RNA levels (>500IU/mL).

Key exclusion criteria (5 listed)

concurrent active hepatitis A or B;
history or evidence of a medical condition associated with chronic liver disease other than HCV;
history or other evidence of decompensated liver disease;
therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment <=6 months prior to study;
acute renal failure.

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]180 micrograms or 135 micrograms sc weekly for 48 weeks	Drug	Peginterferon Alpha-2a

Primary outcome

Percentage of Participants Achieving Sustained Virologic Response at 24 Weeks Following Treatment Completion
Time frame: At Week 72
Sustained virologic response is defined as undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels (<50 international units [IU]/mL) at 24 weeks following the completion of 48 weeks treatment period (Week 72).
Percentage of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid Level at Week 24 and Week 48
Time frame: At Week 24 and Week 48
HCV RNA level less than 50 IU/mL was considered to be undetectable.
Percentage of Participants With At Least a 2log10 Drop in Hepatitis C Virus Ribonucleic Acid at Week 24 as Compared to Baseline
Time frame: From Baseline (Days -30 to -1) and Week 24
The table below shows the percentage of participants with at least 2log10 drop in HCV RNA level at Week 24 as compared to Baseline (Screening visit [Days -30 to -1]).

5 secondary outcomes

Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events
Time frame: Up to Week 72
Number of Participants Who Prematurely Withdrew From the Treatment Over a Period of 48 Weeks
Time frame: Up to Week 48
Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
Time frame: Up to Week 72
Mean Change From Baseline in Blood Pressure up to Week 72
Time frame: From Baseline (Days -30 to -1) to Week 72
Mean Change From Baseline in Heart Rate up to Week 72
Time frame: From Baseline (Days -30 to -1) to Week 72

Results and safety

Results posted to the registry on 25 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Peginterferon Alpha-2a	27	19

Primary outcome: Percentage of Participants Achieving Sustained Virologic Response at 24 Weeks Following Treatment Completion

Time frame: At Week 72. Number. Unit: Percentage of participants

Measure	Peginterferon Alpha-2a n = 27
Value	55.6

Population analysed: ITT population included all enrolled participants who received at least one dose of study medication.

Primary outcome: Percentage of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid Level at Week 24 and Week 48

Time frame: At Week 24 and Week 48. Number. Unit: Percentage of participants

Measure	Peginterferon Alpha-2a n = 27
At Week 24	59.3
At Week 48	48.1

Population analysed: ITT population included all enrolled participants who received at least one dose of study medication.

Primary outcome: Percentage of Participants With At Least a 2log10 Drop in Hepatitis C Virus Ribonucleic Acid at Week 24 as Compared to Baseline

Time frame: From Baseline (Days -30 to -1) and Week 24. Number. Unit: Percentage of participants

Measure	Peginterferon Alpha-2a n = 27
Value	33.3

Population analysed: ITT population included all enrolled participants who received at least one dose of study medication.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Week 72. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Peginterferon Alpha-2a	2 of 27 (7.4%)	10 of 27 (37%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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

5 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] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 5 sites in Russia.

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 5 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 25 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Russia. 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 25 Jul 2016). 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 Participants Achieving Sustained Virologic Response at 24 Weeks Following Treatment Completion (time frame: At Week 72). The study lists 3 primary outcomes in all. 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 NCT00474955.

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 25 Jul 2016.