Hepatitis C, ChronicPhase 3NCT02806505
HELPS Study - A Study of Peginterferon Alfa-2a (Pegasys) in Patients With Chronic Hepatitis C (CHC) and End-Stage Renal Disease (ESRD)
A Phase 3 study testing Peginterferon alfa-2a in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 22 sites in 8 countries.
Trial summary
This study evaluated the safety and efficacy of peginterferon alfa-2a monotherapy in participants with Chronic Hepatitis C (CHC) who have End-Stage Renal Disease (ESRD) and were undergoing hemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- Peginterferon alfa-2a
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 22 sitesin 8 countries
- Study dates
- Jun 2004to Aug 2007
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Serum hepatitis C virus ribonucleic acid (HCV RNA) quantifiable at greater than (>) 600 IU/mL
- Liver biopsy consistent with chronic hepatitis C infection obtained within 2 years of enrollment
- Compensated liver disease without cirrhosis
- Participants with end-stage renal disease undergoing hemodialysis
- Negative serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
- All fertile participants must have been using effective contraception during treatment with study drug
Who cannot join
- Interferon therapy at any previous time
- Liver cirrhosis
- Signs and symptoms of hepatocellular carcinoma
- History or other evidence of decompensated liver disease
- Any investigational drug less than or equal to 6 weeks prior to the first dose of study drug
- History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
Show all 14Show fewer
- Poorly controlled diabetes
- Thyroid dysfunction not adequately controlled
- Evidence of severe retinopathy or clinically relevant ophthalmological disorder
- Severe hyperparathyroidism defined as intact Parathyroid Hormone (PTH) > 800 picogram/milliliter (pg/mL)
- Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment ≤ 6 months prior to the first dose of study drug
- Acute renal failure
- Women with ongoing pregnancy or breast feeding
- Positive test at screening for anti-HAV IgM Ab (hepatitis A virus immunoglobulin M antibody), hepatitis B surface antigen (HBsAg), anti-HBc (hepatitis B core) IgM Ab, anti-HIV (human immunodeficiency virus) Ab
Trial locations and contacts
22 sites in 8 countries.
22 sites in 8 countries
France6 sites
Study site
Créteil, 94010
Study site
Le Kremlin-Bicêtre, 94275
Study site
Marseille, 13385
Study site
Paris, 75747
Study site
Strasbourg, 67091
Study site
Toulouse, 31059
Brazil5 sites
Study site
Brasília, 70335-000
Study site
Porto Alegre, 90035-003
Study site
Sao Jose Rio Preto, 15090-003
Study site
São Luís, 78048-790
Study site
São Paulo, 04023-900
Turkey (Türkiye)4 sites
Study site
Istanbul, 34303
Study site
Istanbul, 34390
Study site
Istanbul, 34662
Study site
Izmir, 35040
About this study
Official title: A Randomized, Open-Label, Multicenter, Parallel Group Study Evaluating the Efficacy and Safety of 135 μg and 90 μg of PEGASYS® Given as Monotherapy to Patients With Chronic Hepatitis C and End-Stage Renal Disease Undergoing Hemodialysis
This study evaluated the safety and efficacy of peginterferon alfa-2a monotherapy in participants with Chronic Hepatitis C (CHC) who have End-Stage Renal Disease (ESRD) and were undergoing hemodialysis.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Peginterferon alfa-2a
- 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-2aDrug
Also called Pegasys
Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a either 135 or 90 mcg SC once weekly up to Week 48.
| Study group | Role | What they receive |
|---|---|---|
| Peginterferon alfa-2a 135 microgram (mcg) | Experimental | Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48. Receives: Drug: Peginterferon alfa-2a |
| Peginterferon alfa-2a 90 mcg | Experimental | Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48. Receives: Drug: Peginterferon alfa-2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Treatment
SVR was defined as the percentage of patients with undetectable HCV RNA. SVR rate was calculated as the number of participants with an undetectable HCV RNA divided by the number of participants of the respective participant population. The last single HCV RNA less than (<) 50 international units per millilitre (IU/mL) measured >=140 days after treatment end (i.e., >= 20 weeks after treatment end) was used to determine SVR. Participants without measurements in this time window were considered to be nonresponders.
Measured: 24 weeks after end of treatment (Week 72)
Secondary outcomes (2)
Percentage of Participants With Virological Response (Non-detectable Hepatitis C Virus-ribonucleic Acid [HCV RNA]) at End of Treatment (EOT)
Virological response at the end of study treatment was defined as the percentage of participants with undetectable HCV RNA. This response rate at end of treatment was calculated as the number of participants with undetectable HCV RNA divided by the number of participants of the respective participant population.
Measured: EOT (Week 48)
Percentage of Participants With Virological Response (at Least a 2-log 10 Decrease in HCV RNA as Compared With Baseline or Unquantifiable [Less Than {<} 600 International Unit/Milliliter {IU/mL}] or Undetectable HCV RNA [< 50 IU/mL]) at Week 12 and 24
Virological response at Weeks 12 and 24 was computed as the percentage of participants with at least a 2-log 10 decrease in HCV RNA at Weeks 12 and 24 as compared with baseline or with an unquantifiable (< 600 IU/mL) or an undetectable HCV RNA test result (< 50 IU/mL) at Week 12 and at Week 24, calculated as the number of participants meeting this criterion divided by the number of participants of the respective participant population.
Measured: Weeks 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startJun 2004
- Primary completionAug 2007
- Study completionAug 2007
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study chair, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806505
- Sponsor's protocol ID
- MV17149
- Status last verified
- Sep 2016
- First submitted
- 16 Jun 2016
- Last updated
- 31 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Prabhu AR, Rao IR, Nagaraju SP, Rajwar E, Venkatesh BT, Nair N S, Pai G, Reddy NP, Suvarna D. Interventions for dialysis patients with hepatitis C virus (HCV) infection. Cochrane Database Syst Rev. 2023 Apr 25;4(4):CD007003. doi: 10.1002/14651858.CD007003.pub3.
PubMed 37096802
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Multicenter, Parallel Group Study Evaluating the Efficacy and Safety of 135 μg and 90 μg of PEGASYS® Given as Monotherapy to Patients With Chronic Hepatitis C and End-Stage Renal Disease Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT02806505
- Acronym / sponsor ID
- MV17149
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 20 Jun 2016 (estimated)
- Results
- Posted 31 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated the safety and efficacy of peginterferon alfa-2a monotherapy in participants with Chronic Hepatitis C (CHC) who have End-Stage Renal Disease (ESRD) and were undergoing hemodialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peginterferon alfa-2a 135 microgram (mcg) | Experimental | Drug: Peginterferon alfa-2aChronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48. |
| Peginterferon alfa-2a 90 mcg | Experimental | Drug: Peginterferon alfa-2aChronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Serum hepatitis C virus ribonucleic acid (HCV RNA) quantifiable at greater than (>) 600 IU/mL
- Liver biopsy consistent with chronic hepatitis C infection obtained within 2 years of enrollment
- Compensated liver disease without cirrhosis
- Participants with end-stage renal disease undergoing hemodialysis
- Negative serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
Key exclusion criteria (14 listed)
- Interferon therapy at any previous time
- Liver cirrhosis
- Signs and symptoms of hepatocellular carcinoma
- History or other evidence of decompensated liver disease
- Any investigational drug less than or equal to 6 weeks prior to the first dose of study drug
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-2aAlso: PegasysChronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a either 135 or 90 mcg SC once weekly up to Week 48. | Drug | Peginterferon alfa-2a 135 microgram (mcg), Peginterferon alfa-2a 90 mcg |
Primary outcome
Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Treatment
Time frame: 24 weeks after end of treatment (Week 72)
SVR was defined as the percentage of patients with undetectable HCV RNA. SVR rate was calculated as the number of participants with an undetectable HCV RNA divided by the number of participants of the respective participant population. The last single HCV RNA less than (<) 50 international units per millilitre (IU/mL) measured >=140 days after treatment end (i.e., >= 20 weeks after treatment end) was used to determine SVR. Participants without measurements in this time window were considered to be nonresponders.
2 secondary outcomes
Percentage of Participants With Virological Response (Non-detectable Hepatitis C Virus-ribonucleic Acid [HCV RNA]) at End of Treatment (EOT)
Time frame: EOT (Week 48)
Percentage of Participants With Virological Response (at Least a 2-log 10 Decrease in HCV RNA as Compared With Baseline or Unquantifiable [Less Than {<} 600 International Unit/Milliliter {IU/mL}] or Undetectable HCV RNA [< 50 IU/mL]) at Week 12 and 24
Time frame: Weeks 12 and 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37096802Prabhu AR, Rao IR, Nagaraju SP, Rajwar E, Venkatesh BT, Nair N S, Pai G, Reddy NP, Suvarna D. Interventions for dialysis patients with hepatitis C virus (HCV) infection. Cochrane Database Syst Rev. 2023 Apr 25;4(4):CD007003. doi: 10.1002/14651858.CD007003.pub3.
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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.
Clinical Trials study chair
Hoffmann-La Roche
22 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Peginterferon alfa-2a in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 22 sites in 8 countries.
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 6 inclusion and 14 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 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in France, Brazil, Turkey (Türkiye), Austria, Greece and 3 more countries. 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?
Yes. Results are posted in the registry (first posted 31 Oct 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 With Sustained Virological Response (SVR) at 24 Weeks After End of Treatment (time frame: 24 weeks after end of treatment (Week 72)). 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 NCT02806505, 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 31 Oct 2016.