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Tailored Regimens of PEGASYS® and Ribavirin for Genotype 1 Chronic Hepatitis C Patients Trial (TARGET-1)

Primary Purpose

Hepatitis C

Status

Completed

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

A: Peg-interferon alpha-2a & Ribavirin

B: Peg-interferon alpha-2a & Ribavirin

C: Peg-interferon alpha-2a & Ribavirin

D: Peg-interferon alpha-2a & Ribavirin

E: Peg-interferon alpha-2a & Ribavirin

F: Peg-interferon alpha-2a & Ribavirin

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C, Genotype 1, Peg interferon, alfa 1a, Ribavirin

Eligibility Criteria

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

Inclusion Criteria:

Male and female patients *18 years of age
Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin
Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
Detectable serum HCV-RNA and HCV viral genotype 1
Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection with or without compensated cirrhosis (Exception: hemophiliacs in whom biopsy is medically contra-indicated do not require biopsy.)
Compensated liver disease (Child-Pugh Grade A clinical classification)
Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
All fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end

Exclusion Criteria:

Women with ongoing pregnancy or breast feeding
Therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) *6 months prior to the first dose of study drug
Any investigational drug *6 weeks prior to the first dose of study drug
Co-infection with active hepatitis A, hepatitis B and/or human immunodeficiency virus (HIV)
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)
Signs or symptoms of hepatocellular carcinoma
History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening

Sites / Locations

Kaohsiung Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

A: Peg-interferon alpha-2a & Ribavirin

B: Peg-interferon alpha-2a & Ribavirin

C: Peg-interferon alpha-2a & Ribavirin

D: Peg-interferon alpha-2a & Ribavirin

E: Peg-interferon alpha-2a & Ribavirin

F: Peg-interferon alpha-2a & Ribavirin

Arm Description

Arm A: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 24 weeks with a follow-up period of 24 weeks.

Arm B: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 36 weeks with a follow-up period of 24 weeks. (Patients who have HVL and an RVR will be randomized into arm B or arm C with a ratio of 1:1)

Arm C: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks. (Patients who have HVL and an RVR will be randomized into arm B or arm C with a ratio of 1:1)

Arm D: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks. (Patients who do not achieve a RVR but have HCV RNA PCR-seronegative at week 12 of treatment)

Arm E: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks. (Patients who do not achieve a RVR and remain HCV RNA PCR-seropositive at week 12 of treatment will be randomized into arm E or arm F a ratio of 1:1)

Arm F: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 72 weeks with a follow-up period of 24 weeks. (Patients who do not achieve a RVR and remain HCV RNA PCR-seropositive at week 12 of treatment will be randomized into arm E or arm F a ratio of 1:1)

Outcomes

Primary Outcome Measures

Efficacy

Rapid virologic response (RVR), HCV RNA seronegative by PCR at week 4 Sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period

Secondary Outcome Measures

Safety

adverse event rate and profile

Full Information

NCT ID

NCT01937728

First Posted

June 21, 2013

Last Updated

December 28, 2016

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01937728

Brief Title

Tailored Regimens of PEGASYS® and Ribavirin for Genotype 1 Chronic Hepatitis C Patients Trial (TARGET-1)

Official Title

A Randomized, Multicenter, Open Label Study Evaluating the Efficacy and Safety of Tailored Regimens With Peginterferon Alfa-2a Plus Ribavirin According Viral Kinetics for Genotype 1 Chronic Hepatitis C Patients

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purposes of this study are: To test if 36 weeks of standard dose of ribavirin with PEGASYS® is non-inferior to standard dose of 48 weeks of ribavirin with PEGASYS® in SVR for patients with RVR and HVL To test if the 72 weeks of treatment with PEGASYS® plus standard dose ribavirin is superior to 48 weeks of the same treatment for patients with HCV RNA seropositivity at week 12

Detailed Description

The aims of the present study are: To evaluate the efficacy and safety of 36-week versus 48-week regimen of PEGASYS® (peginterferon alfa-2a, PegIFN) plus standard-dose of ribavirin (RBV) in hepatitis C virus (HCV) genotype 1 infected, treatment-naïve CHC patients who have high viral loads (HVL, defined as baseline HCV RNA ≧ 400,000 IU/mL) and achieve a rapid virologic response (RVR) (defined as seronegativity of HCV RNA at week 4 of treatment) To evaluate the efficacy and safety of 48-week versus 72-week regimen of PegIFN plus standard-dose of RBV in HCV virus genotype 1 infected, treatment-naïve CHC patients with PCR-seropositive of HCV RNA at week 12

6. Conditions and Keywords

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

Hepatitis C

Keywords

Hepatitis C, Genotype 1, Peg interferon, alfa 1a, Ribavirin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

542 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A: Peg-interferon alpha-2a & Ribavirin

Arm Type

Active Comparator

Arm Description

Arm A: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 24 weeks with a follow-up period of 24 weeks.

Arm Title

B: Peg-interferon alpha-2a & Ribavirin

Arm Type

Experimental

Arm Description

Arm Title

C: Peg-interferon alpha-2a & Ribavirin

Arm Type

Experimental

Arm Description

Arm Title

D: Peg-interferon alpha-2a & Ribavirin

Arm Type

Active Comparator

Arm Description

Arm Title

E: Peg-interferon alpha-2a & Ribavirin

Arm Type

Experimental

Arm Description

Arm Title

F: Peg-interferon alpha-2a & Ribavirin

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

A: Peg-interferon alpha-2a & Ribavirin

Other Intervention Name(s)

Pegasys & Robatrol

Intervention Description

Arm A: Patients who have low viral loads (LVL, defined as baseline HCV RNA < 400,000 IU/mL) and RVR will be treated with PEGASYS 180ug/week and Ribavirin 1000-1200 mg/day for 24 weeks with a follow-up period of 24 weeks.

Intervention Type

Drug

Intervention Name(s)

B: Peg-interferon alpha-2a & Ribavirin

Other Intervention Name(s)

Pegasys & Robatrol

Intervention Description

Patients who have HVL and an RVR will be randomized into arm B or arm C with a ratio of 1:1. Arm B: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 36 weeks with a follow-up period of 24 weeks.

Intervention Type

Drug

Intervention Name(s)

C: Peg-interferon alpha-2a & Ribavirin

Other Intervention Name(s)

Pegasys, Robatrol

Intervention Description

Patients who have HVL and an RVR will be randomized into arm B or arm C with a ratio of 1:1. Arm C: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks.

Intervention Type

Drug

Intervention Name(s)

D: Peg-interferon alpha-2a & Ribavirin

Other Intervention Name(s)

PEGASYS, Robatrol

Intervention Description

Arm D: Patients who do not achieve a RVR but have HCV RNA PCR-seronegative at week 12 of treatment will be treated with PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks.

Intervention Type

Drug

Intervention Name(s)

E: Peg-interferon alpha-2a & Ribavirin

Other Intervention Name(s)

Pegasys, Robatrol

Intervention Description

Patients who do not achieve a RVR and remain HCV RNA PCR-seropositive at week 12 of treatment will be randomized into arm E or arm F with a ratio of 1:1. Arm E: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks.

Intervention Type

Drug

Intervention Name(s)

F: Peg-interferon alpha-2a & Ribavirin

Other Intervention Name(s)

Pegasys, Robatrol

Intervention Description

Patients who do not achieve a RVR and remain HCV RNA PCR-seropositive at week 12 of treatment will be randomized into arm E or arm F with a ratio of 1:1. Arm F: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 72 weeks with a follow-up period of 24 weeks.

Primary Outcome Measure Information:

Title

Efficacy

Description

Rapid virologic response (RVR), HCV RNA seronegative by PCR at week 4 Sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period

Time Frame

24-week off-treatment period

Secondary Outcome Measure Information:

Title

Safety

Description

adverse event rate and profile

Time Frame

24-week off-treatment period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female patients *18 years of age Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test Detectable serum HCV-RNA and HCV viral genotype 1 Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection with or without compensated cirrhosis (Exception: hemophiliacs in whom biopsy is medically contra-indicated do not require biopsy.) Compensated liver disease (Child-Pugh Grade A clinical classification) Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug All fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end Exclusion Criteria: Women with ongoing pregnancy or breast feeding Therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) *6 months prior to the first dose of study drug Any investigational drug *6 weeks prior to the first dose of study drug Co-infection with active hepatitis A, hepatitis B and/or human immunodeficiency virus (HIV) 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) Signs or symptoms of hepatocellular carcinoma History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chia-Yen Dai, M.D., PhD.

Organizational Affiliation

Kaohsiung Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kaohsiung Medical University Hospital

City

Kaohsiung

Country

Taiwan

12. IPD Sharing Statement

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Tailored Regimens of PEGASYS® and Ribavirin for Genotype 1 Chronic Hepatitis C Patients Trial (TARGET-1)

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