Efficacy and Safety of Short Course Therapy With Peginterferon Alpha-2b (PEG-IFN Alfa-2b) and Ribavirin (RBV) for Chronic Hepatitis C (Genotype 4) Participants Achieving a Rapid Virological Response at Week 4 of Treatment (MK-8908B-059) (START 4)

• ClinicalTrials.gov Identifier: NCT01606800
• Recruitment Status: Terminated
• First Posted: May 28, 2012
• Results First Posted: February 23, 2016
• Last Update Posted: October 25, 2018
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hepatitis C, Chronic
• Interventions: Drug: PEG-IFN alfa-2b; Drug: ribavirin
• Enrollment: 45

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	44 Weeks of PEG-IFN Alfa-2b + RBV	20 Weeks of PEG-IFN Alfa-2b + RBV
Arm/Group Description	Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks.	Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks.
Period Title: Overall Study
Started	22	23
Treated	22	23
Completed	17	21
Not Completed	5	2
Reason Not Completed
Adverse Event	3	1
Participant withdrew consent	0	1
Missing completion status	2	0

Baseline Characteristics

Arm/Group Title		44 Weeks of PEG-IFN Alfa-2b + RBV	20 Weeks of PEG-IFN Alfa-2b + RBV	Total
Arm/Group Description		Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks.	Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks.	Total of all reporting groups
Overall Number of Baseline Participants		22	23	45
Baseline Analysis Population Description		All Treated Population, which included all participants who received at least one dose of study medication after RVR.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	22 participants	23 participants	45 participants
		38.4 (10.79)	37.1 (11.22)	37.7 (10.91)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	22 participants	23 participants	45 participants
	Female	9 40.9%	10 43.5%	19 42.2%
	Male	13 59.1%	13 56.5%	26 57.8%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Achieving Sustained Virologic Response (SVR)
Description	SVR was defined as undetectable HCV RNA levels 24 weeks after the completion of therapy.
Time Frame	At 24 weeks after the completion of therapy (up to 72 weeks)

Outcome Measure Data

Analysis Population Description

All Treated Population, which included all participants who received at least one dose of study medication after RVR.

Arm/Group Title	44 Weeks of PEG-IFN Alfa-2b + RBV	20 Weeks of PEG-IFN Alfa-2b + RBV
Arm/Group Description:	Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks.	Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks.
Overall Number of Participants Analyzed	22	23
Measure Type: Number; Unit of Measure: Participants
	13	22

Adverse Events

Time Frame	Up to 72 weeks
Adverse Event Reporting Description	All Treated Population, which included all participants who received at least one dose of study medication after RVR.
Arm/Group Title	44 Weeks of PEG-IFN Alfa-2b + RBV	20 Weeks of PEG-IFN Alfa-2b + RBV
Arm/Group Description	Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks.	Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks.
All-Cause Mortality
	44 Weeks of PEG-IFN Alfa-2b + RBV	20 Weeks of PEG-IFN Alfa-2b + RBV
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	44 Weeks of PEG-IFN Alfa-2b + RBV	20 Weeks of PEG-IFN Alfa-2b + RBV
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/22 (0.00%)	2/23 (8.70%)
Blood and lymphatic system disorders
Anemia † 1	0/22 (0.00%)	1/23 (4.35%)
Leukopaenia † 1	0/22 (0.00%)	1/23 (4.35%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, 15.1
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	44 Weeks of PEG-IFN Alfa-2b + RBV	20 Weeks of PEG-IFN Alfa-2b + RBV
	Affected / at Risk (%)	Affected / at Risk (%)
Total	16/22 (72.73%)	13/23 (56.52%)
Blood and lymphatic system disorders
Anemia † 1	5/22 (22.73%)	2/23 (8.70%)
Eye disorders
Vision blurred † 1	2/22 (9.09%)	1/23 (4.35%)
Gastrointestinal disorders
Abdominal pain upper † 1	2/22 (9.09%)	1/23 (4.35%)
General disorders
Fatigue † 1	5/22 (22.73%)	1/23 (4.35%)
Pyrexia † 1	2/22 (9.09%)	0/23 (0.00%)
Investigations
Blood thyroid stimulating hormone increased † 1	2/22 (9.09%)	2/23 (8.70%)
Musculoskeletal and connective tissue disorders
Bone pain † 1	2/22 (9.09%)	1/23 (4.35%)
Arthralgia † 1	2/22 (9.09%)	0/23 (0.00%)
Nervous system disorders
Headache † 1	3/22 (13.64%)	1/23 (4.35%)
Respiratory, thoracic and mediastinal disorders
Cough † 1	2/22 (9.09%)	2/23 (8.70%)
Dyspnoea † 1	2/22 (9.09%)	0/23 (0.00%)
Skin and subcutaneous tissue disorders
Pruritus † 1	3/22 (13.64%)	2/23 (8.70%)
Alopecia † 1	0/22 (0.00%)	2/23 (8.70%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, 15.1

Limitations and Caveats

This Trial was prematurely terminated due to the availability of more promising treatment for HCV participants and the change in treatment guidelines, which will offer the patient a better treatment opportunity.

More Information

Certain Agreements

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

There IS 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.

The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication (including, without limitation, slides and texts of oral or other public presentations and texts of any transmission through any electronic media, eg, any computer access system such as the Internet, World Wide Web, etc) that report any results of the trial.

Results Point of Contact

• Name/Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.
• Phone: 1-800-672-6372
• EMail: ClinicalTrialsDisclosure@merck.com

• Responsible Party: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT01606800 History of Changes
• Other Study ID Numbers: 8908B-059; MK-8908B-059 ( Other Identifier: Merck Registration Number )
• First Submitted: May 24, 2012
• First Posted: May 28, 2012
• Results First Submitted: January 26, 2016
• Results First Posted: February 23, 2016
• Last Update Posted: October 25, 2018