Trial Outcomes & Findings for 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) (NCT NCT01606800)
NCT ID: NCT01606800
Last Updated: 2018-10-25
Results Overview
SVR was defined as undetectable HCV RNA levels 24 weeks after the completion of therapy.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
45 participants
Primary outcome timeframe
At 24 weeks after the completion of therapy (up to 72 weeks)
Results posted on
2018-10-25
Participant Flow
Participant milestones
| Measure |
44 Weeks of PEG-IFN Alfa-2b + RBV
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.
|
20 Weeks of PEG-IFN Alfa-2b + RBV
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 Study
STARTED
|
22
|
23
|
|
Overall Study
Treated
|
22
|
23
|
|
Overall Study
COMPLETED
|
17
|
21
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
44 Weeks of PEG-IFN Alfa-2b + RBV
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.
|
20 Weeks of PEG-IFN Alfa-2b + RBV
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 Study
Adverse Event
|
3
|
1
|
|
Overall Study
Participant withdrew consent
|
0
|
1
|
|
Overall Study
Missing completion status
|
2
|
0
|
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
44 Weeks of PEG-IFN Alfa-2b + RBV
n=22 Participants
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.
|
20 Weeks of PEG-IFN Alfa-2b + RBV
n=23 Participants
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
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.4 Years
STANDARD_DEVIATION 10.79 • n=5 Participants
|
37.1 Years
STANDARD_DEVIATION 11.22 • n=7 Participants
|
37.7 Years
STANDARD_DEVIATION 10.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 24 weeks after the completion of therapy (up to 72 weeks)Population: All Treated Population, which included all participants who received at least one dose of study medication after RVR.
SVR was defined as undetectable HCV RNA levels 24 weeks after the completion of therapy.
Outcome measures
| Measure |
44 Weeks of PEG-IFN Alfa-2b + RBV
n=22 Participants
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.
|
20 Weeks of PEG-IFN Alfa-2b + RBV
n=23 Participants
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.
|
|---|---|---|
|
Number of Participants Achieving Sustained Virologic Response (SVR)
|
13 Participants
|
22 Participants
|
Adverse Events
44 Weeks of PEG-IFN Alfa-2b + RBV
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
20 Weeks of PEG-IFN Alfa-2b + RBV
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
44 Weeks of PEG-IFN Alfa-2b + RBV
n=22 participants at risk
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.
|
20 Weeks of PEG-IFN Alfa-2b + RBV
n=23 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/22 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
4.3%
1/23 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
|
Blood and lymphatic system disorders
Leukopaenia
|
0.00%
0/22 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
4.3%
1/23 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
Other adverse events
| Measure |
44 Weeks of PEG-IFN Alfa-2b + RBV
n=22 participants at risk
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.
|
20 Weeks of PEG-IFN Alfa-2b + RBV
n=23 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
22.7%
5/22 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
8.7%
2/23 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
|
Eye disorders
Vision blurred
|
9.1%
2/22 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
4.3%
1/23 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.1%
2/22 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
4.3%
1/23 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
|
General disorders
Fatigue
|
22.7%
5/22 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
4.3%
1/23 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
|
General disorders
Pyrexia
|
9.1%
2/22 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
0.00%
0/23 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
9.1%
2/22 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
8.7%
2/23 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.1%
2/22 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
4.3%
1/23 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
2/22 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
0.00%
0/23 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
|
Nervous system disorders
Headache
|
13.6%
3/22 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
4.3%
1/23 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
2/22 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
8.7%
2/23 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.1%
2/22 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
0.00%
0/23 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.6%
3/22 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
8.7%
2/23 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/22 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
8.7%
2/23 • Up to 72 weeks
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER