FAST-4: Rate and Predictors of Relapse in the Treatment of Hepatitis C (Study P05181)

• Sponsor: Merck Sharp & Dohme LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00723645
• Collaborator: (none)
• Enrollment: 279
• Duration (Months): 34

Study Details

Study Description

Brief Summary

This is an observational, multicenter, nationwide study where information will be collected on the follow-up of participants with chronic hepatitis C virus (HCV) who have a viral response at the end of treatment with pegylated interferon alfa-2b (PEG IFN alfa-2b) plus ribavirin (RBV) administered according to the directions on the products' labeling. No administration of treatment is planned as a result of study enrollment.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C, Chronic

Study Design

• Study Type: Observational
• Actual Enrollment: 279 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Rate and Predictors of Relapse in the Treatment of Hepatitis C in Real-life Clinical Practice in Spanish Hospitals (FAST-4)
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
PEG IFN alfa-2b + RBV Adult participants with chronic hepatitis C who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment during this study.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Relapse At 24 Weeks After the End Of Treatment (EOT) [From enrollment (≤4 weeks after end of treatment) to Week 24 post-treatment]

   Relapse rate is defined as the percentage of participants with negative viral load (HCV RNA-) at EOT who have positive viral load (HCV RNA+) at 6 months after EOT. RNA= Ribonucleic Acid

Secondary Outcome Measures

1. Percentage of Participants Who Relapsed After EOT at Week 72 (Late Relapser) [From 24 weeks post-treatment to 72 weeks post-treatment]

   Late relapse was defined as having a Sustained Viral Response (SVR) at 24 weeks of follow-up and subsequently having a positive viral load 48 weeks later at Week 72. SVR was defined as negative for HCV RNA at Week 24 of follow-up.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants with chronic hepatitis C virus (HCV)[any genotype] who received pegylated interferon alfa-2b plus ribavirin as first treatment for hepatitis C.

• Negative HCV RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate), measured by the assay used at each institution. Only institutions using an assay with a limit of detection of 50 IU/mL or less will be eligible.

Exclusion Criteria:

• Women of childbearing potential (i.e., premenopausal women and women who are less than 6 months postmenopausal) who will not use an appropriate contraceptive method during the course of the clinical study. Appropriate contraceptives include double barrier methods (eg, diaphragm or condom plus spermicide), intrauterine device, oral, injectable or subcutaneous hormonal contraceptive, or surgically sterilized partner.

• Completed treatment with pegylated interferon alfa-2b plus ribavirin more than 4 weeks before study entry.

• Positive HCV RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate).

• Participants treated for a period shorter than the enrollment period.

• Co-infection with Human Immumodeficiency Virus (HIV).

• Co-infected with Hepatitis B Virus (HBV).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Merck Sharp & Dohme LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT00723645
• Other Study ID Numbers: P05181
• First Posted: Jul 29, 2008
• Last Update Posted: Nov 30, 2015
• Last Verified: Nov 1, 2015

• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis

Study Results

Participant Flow

Recruitment Details	Participants who had achieved a viral response prior to this study (negative for Hepatitis C Virus [HCV] ribonucleic acid [RNA] at the end of treatment as per product label) were recruited for follow-up on the present study.
Pre-assignment Detail	A total of 279 participants enrolled in the study. Twenty-one participants failed screening and 258 participants were evaluable at Visit 1 (V1), which could be performed up to Week (Wk) 4 after the end of treatment.

Arm/Group Title	PEG IFN Alfa-2b + RBV
Arm/Group Description	Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
Period Title: Visit 1 (≤4 Weeks Post-treatment)
STARTED	258
COMPLETED	258
NOT COMPLETED	0
Period Title: Visit 1 (≤4 Weeks Post-treatment)
STARTED	248
COMPLETED	248
NOT COMPLETED	0
Period Title: Visit 1 (≤4 Weeks Post-treatment)
STARTED	187
COMPLETED	187
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	PEG IFN Alfa-2b + RBV
Arm/Group Description	Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
Overall Participants	258
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.72 (9.94)
Sex: Female, Male (Count of Participants)
Female	106 41.1%
Male	152 58.9%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Relapse At 24 Weeks After the End Of Treatment (EOT)
Description	Relapse rate is defined as the percentage of participants with negative viral load (HCV RNA-) at EOT who have positive viral load (HCV RNA+) at 6 months after EOT. RNA= Ribonucleic Acid
Time Frame	From enrollment (≤4 weeks after end of treatment) to Week 24 post-treatment

Outcome Measure Data

Analysis Population Description

The evaluable population consisted of all enrolled participants who were virus negative at the end of treatment. 249 participants were evaluable for Week 24 (Visit 2).

Arm/Group Title	PEG IFN Alfa-2b + RBV
Arm/Group Description	Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
Measure Participants	249
Number (95% Confidence Interval) [Percentage of participants]	13.65 5.3%

2. Secondary Outcome

Title	Percentage of Participants Who Relapsed After EOT at Week 72 (Late Relapser)
Description	Late relapse was defined as having a Sustained Viral Response (SVR) at 24 weeks of follow-up and subsequently having a positive viral load 48 weeks later at Week 72. SVR was defined as negative for HCV RNA at Week 24 of follow-up.
Time Frame	From 24 weeks post-treatment to 72 weeks post-treatment

Outcome Measure Data

Analysis Population Description

The evaluable population consisted of all enrolled participants who were virus negative at the end of treatment and also virus-negative at Week 24 (Visit 2). 187 participants completed Visit 2, 14 participants were excluded from analysis, and 173 participants were evaluable for Week 72 (Visit 3).

Arm/Group Title	PEG IFN Alfa-2b + RBV
Arm/Group Description	Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
Measure Participants	173
Number (95% Confidence Interval) [Percentage of participants]	0.58 0.2%

Adverse Events

Arm/Group Title	PEG IFN Alfa-2b + RBV
Arm/Group Description	Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
All Cause Mortality
	PEG IFN Alfa-2b + RBV
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	PEG IFN Alfa-2b + RBV
	Affected / at Risk (%)	# Events
Total	5/258 (1.9%)
General disorders
Drowning	1/258 (0.4%)	1
Nervous system disorders
Cerebrovascular accident	1/258 (0.4%)	1
Spinal Hematoma	1/258 (0.4%)	1
Pregnancy, puerperium and perinatal conditions
Pregnancy	1/258 (0.4%)	1
Psychiatric disorders
Depression	1/258 (0.4%)	1
Schizophrenia, Paranoid Type	1/258 (0.4%)	1
Other (Not Including Serious) Adverse Events
	PEG IFN Alfa-2b + RBV
	Affected / at Risk (%)	# Events
Total	26/258 (10.1%)
Blood and lymphatic system disorders
Anemia	13/258 (5%)	13
General disorders
Asthenia	16/258 (6.2%)	16

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.