HELPS Study - A Study of Peginterferon Alfa-2a (Pegasys) in Patients With Chronic Hepatitis C (CHC) and End-Stage Renal Disease (ESRD) - Clinical Trial for Hepatitis C, Chronic | NCT02806505

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Peginterferon alfa-2a

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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)
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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Peginterferon alfa-2a 135 microgram (mcg)

Peginterferon alfa-2a 90 mcg

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT02806505

First Posted

June 16, 2016

Last Updated

September 9, 2016

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT02806505

Brief Title

HELPS Study - A Study of Peginterferon Alfa-2a (Pegasys) in Patients With Chronic Hepatitis C (CHC) and End-Stage Renal Disease (ESRD)

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

June 2004 (undefined)

Primary Completion Date

August 2007 (Actual)

Study Completion Date

August 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C, Chronic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Peginterferon alfa-2a 135 microgram (mcg)

Arm Type

Experimental

Arm Description

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.

Arm Title

Peginterferon alfa-2a 90 mcg

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Peginterferon alfa-2a

Other Intervention Name(s)

Pegasys

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Treatment

Description

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.

Time Frame

24 weeks after end of treatment (Week 72)

Secondary Outcome Measure Information:

Title

Percentage of Participants With Virological Response (Non-detectable Hepatitis C Virus-ribonucleic Acid [HCV RNA]) at End of Treatment (EOT)

Description

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.

Time Frame

EOT (Week 48)

Title

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

Description

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.

Time Frame

Weeks 12 and 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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) 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Chair

Facility Information:

City

Graz

ZIP/Postal Code

8036

Country

Austria

City

Wien

ZIP/Postal Code

1090

Country

Austria

City

Brasilia

ZIP/Postal Code

70335-000

Country

Brazil

City

Porto Alegre

ZIP/Postal Code

90035-003

Country

Brazil

City

Sao Jose Rio Preto

ZIP/Postal Code

15090-003

Country

Brazil

City

Sao Luis

ZIP/Postal Code

78048-790

Country

Brazil

City

Sao Paulo

ZIP/Postal Code

04023-900

Country

Brazil

City

Creteil

ZIP/Postal Code

94010

Country

France

City

Le Kremlin-bicetre

ZIP/Postal Code

94275

Country

France

City

Marseille

ZIP/Postal Code

13385

Country

France

City

Paris

ZIP/Postal Code

75747

Country

France

City

Strasbourg

ZIP/Postal Code

67091

Country

France

City

Toulouse

ZIP/Postal Code

31059

Country

France

City

Athens

ZIP/Postal Code

11527

Country

Greece

City

Nikea

ZIP/Postal Code

18354

Country

Greece

City

Medan

ZIP/Postal Code

20119

Country

Indonesia

City

Cagliari

ZIP/Postal Code

09134

Country

Italy

City

Istanbul

ZIP/Postal Code

34303

Country

Turkey

City

Istanbul

ZIP/Postal Code

34390

Country

Turkey

City

Istanbul

ZIP/Postal Code

34662

Country

Turkey

City

Izmir

ZIP/Postal Code

35040

Country

Turkey

City

Abu Dhabi

Country

United Arab Emirates

HELPS Study - A Study of Peginterferon Alfa-2a (Pegasys) in Patients With Chronic Hepatitis C (CHC) and End-Stage Renal Disease (ESRD)

Hepatitis C, Chronic

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial