Safety and Efficacy of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03523AM2) (COMPLETED)

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00423670

First received: January 17, 2007

Last updated: March 15, 2013

Last verified: March 2013

History of Changes

Results First Received: May 13, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Chronic Hepatitis C
Interventions:	Drug: boceprevir (SCH 503034) Drug: peginterferon-alfa 2b (PegIntron) Drug: ribavirin Drug: ribavirin (low-dose)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
765 participants were screened in the study, 598 were randomized of which 3 participants were not treated (Arm 1-7). Participants were assigned to Part I (with standard dosing for ribavirin) or Part II (to explore low-dose ribavirin). All participants that completed or discontinued treatment were scheduled to enter follow-up phase per protocol.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants in Arm 1 (Part I) who had detectable Hepatitis C Virus-ribonucleic acid (HCV-RNA) at Treatment Week (TW) 24 were offered boceprevir in addition to PegIntron and ribavirin for an additional 24 weeks of treatment, and switched to a new arm, Arm 8.

Reporting Groups

	Description
Arm 1. PEG +RBV for 48 Wks (Part I)	PegIntron (1.5 μg/kg, once weekly [QW]) plus ribavirin (800 to 1400 mg/day) for 48 weeks. • Participants with detectable HCV-RNA levels after 24 weeks of treatment had the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg, thrice a day [TID]) for 24 additional weeks. Total treatment duration was up to 54 weeks.
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)	Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)	PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)	Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
Arm 5. PEG + RBV + BOC (From Wk 4) for 44 Wks (Part I)	PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)	PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)	PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
Arm 8. PEG + RBV + BOC (From Wk 24) for 48 Wks (Part I)	Participants that started in Arm 1 and had detectable HCV-RNA levels after 24 weeks of treatment had the option of receiving boceprevir (800 mg TID) with PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day). Participants that took the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg TID) for 24 additional weeks constitute Arm 8. The total treatment duration was up to 54 weeks.

Participant Flow for 2 periods

Period 1: Treatment Period

	Arm 1. PEG +RBV for 48 Wks (Part I)	Arm 2. PEG + RBV + BOC for 28 Wks (Part I)	Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)	Arm 4. PEG +RBV + BOC for 48 Wks (Part I)	Arm 5. PEG + RBV + BOC (From Wk 4) for 44 Wks (Part I)	Arm 6. PEG + RBV + BOC for 48 Wks (Part II)	Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)	Arm 8. PEG + RBV + BOC (From Wk 24) for 48 Wks (Part I)
STARTED	104	107	103	103	103	16	59	36 ^[1]
COMPLETED	52	77	76	63	76	8	28	15
NOT COMPLETED	52	30	27	40	27	8	31	21
Switched to Arm 8 at TW 24	36	0	0	0	0	0	0	0
Adverse Event	8	12	15	20	9	4	7	2
Protocol-defined clinical event	0	7	4	12	5	4	16	15
Lost to Follow-up	2	1	3	1	6	0	3	1
Subject withdrew (not treatment related)	3	9	4	4	5	0	3	0
Investigator decision	0	0	0	0	0	0	0	1
Non-compliance with protocol	3	1	1	3	2	0	2	2

[1]	Arm 8 were Arm 1 participants that were positive for HCV-RNA at TW 24 and had the option to switch.

Period 2: Follow-up Period

	Arm 1. PEG +RBV for 48 Wks (Part I)	Arm 2. PEG + RBV + BOC for 28 Wks (Part I)	Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)	Arm 4. PEG +RBV + BOC for 48 Wks (Part I)	Arm 5. PEG + RBV + BOC (From Wk 4) for 44 Wks (Part I)	Arm 6. PEG + RBV + BOC for 48 Wks (Part II)	Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)	Arm 8. PEG + RBV + BOC (From Wk 24) for 48 Wks (Part I)
STARTED	97	100	96	96	91	14	50	35
COMPLETED	94	84	85	91	89	14	41	32
NOT COMPLETED	3	16	11	5	2	0	9	3
Lost to Follow-up	0	12	8	3	1	0	5	0
Subject withdrew (not treatment related)	1	4	2	1	1	0	1	1
Non-compliance with protocol	2	0	1	1	0	0	3	2

Baseline Characteristics

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Reporting Groups

	Description
Arm 1. PEG +RBV for 48 Wks (Part I)	PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks. • Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks.
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)	Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)	PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)	Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)	PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)	PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)	PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
Total	Total of all reporting groups

Baseline Measures

	Arm 1. PEG +RBV for 48 Wks (Part I)	Arm 2. PEG + RBV + BOC for 28 Wks (Part I)	Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)	Arm 4. PEG +RBV + BOC for 48 Wks (Part I)	Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)	Arm 6. PEG + RBV + BOC for 48 Wks (Part II)	Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)	Total
Number of Participants [units: participants]	104	107	103	103	103	16	59	595
Age ^[1] [units: years] Mean ± Standard Deviation	48.3 ± 6.9	46.4 ± 8.0	47.7 ± 7.4	46.7 ± 8.8	47.6 ± 8.3	50.3 ± 8.5	48.7 ± 5.8	47.5 ± 7.7
Gender ^[2] [units: participants]
Female	34	44	52	40	45	7	18	240
Male	70	63	51	63	58	9	41	355

[1]	Overall age characteristics were displayed for Arm 1 through Arm 7. Participants from Arm 1 (Part I) who had detectable HCV-RNA at TW 24, had the option to switch to a new arm, Arm 8.
[2]	Overall gender characteristics were displayed for Arm 1 through Arm 7. Participants from Arm 1 (Part I) who had detectable HCV-RNA TW 24, had the option to switch to a new arm, Arm 8.

Outcome Measures

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1. Primary:

Number of Participants With Sustained Virologic Response (SVR) [ Time Frame: From follow-up week (FW) 24 up to end of follow-up (EOF) ]

Show Outcome Measure 1

2. Secondary:

Number of Participants With SVR Based on a 4-week lead-in Treatment With PegIntron and Ribavirin [ Time Frame: From FW 24 up to EOF ]

Show Outcome Measure 2

3. Secondary:

Number of Participants With SVR Based on Duration of Boceprevir Treatment [ Time Frame: From FW 24 up to EOF ]

Show Outcome Measure 3

4. Secondary:

Number of Participants Negative for HCV-RNA at FW 12 [ Time Frame: At FW 12 ]

Show Outcome Measure 4

5. Secondary:

Number of Participants Negative for HCV-RNA at 72 Weeks Post Randomization [ Time Frame: 72 weeks post randomization ]

Show Outcome Measure 5

6. Secondary:

Number of Participants With an Early Virologic Response (EVR) That Achieved SVR [ Time Frame: At TW 12, and at FW 24 up to EOF ]

Show Outcome Measure 6

7. Secondary:

Number of Participants With a Virologic Response at Follow-up Week 12 That Achieved SVR [ Time Frame: At FW 12 and FW 24 up to EOF ]

Show Outcome Measure 7

8. Secondary:

Number of Participants With a Virologic Response at 72 Weeks Post Randomization That Achieved SVR [ Time Frame: At FW 24 up to EOF and at 72 weeks post randomization ]

Show Outcome Measure 8

Serious Adverse Events

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Reporting Groups

	Description
PEG +RBV for 48 Wks (Part I)	Arm 1. PegIntron (1.5 μg/kg, once weekly [QW]) plus ribavirin (800 to 1400 mg/day) for 48 weeks. • Participants with detectable HCV-RNA levels after 24 weeks of treatment had the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg, thrice a day [TID]) for 24 additional weeks. Total treatment duration was up to 54 weeks. Adverse events for 36 participants after they crossed over to Arm 8 are not included.
PEG + RBV + BOC for 28 Wks (Part I)	Arm 2. Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)	Arm 3. PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
PEG +RBV + BOC for 48 Wks (Part I)	Arm 4. Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
PEG + RBV + BOC (From Wk 4) for 44 Wks (Part I)	Arm 5. PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
PEG + RBV + BOC for 48 Wks (Part II)	Arm 6. PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
PEG +Low-dose RBV + BOC for 48 Wks (Part II)	Arm 7. PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
PEG + RBV + BOC (From Wk 24) for 48 Wks (Part I)	Arm 8. Participants that started in Arm 1 and had detectable HCV-RNA levels after 24 weeks of treatment had the option of receiving boceprevir (800 mg TID) with PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day). Participants that took the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg TID) for 24 additional weeks constitute Arm 8. The total treatment duration was up to 54 weeks.

Serious Adverse Events

	PEG +RBV for 48 Wks (Part I)	PEG + RBV + BOC for 28 Wks (Part I)	PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)	PEG +RBV + BOC for 48 Wks (Part I)	PEG + RBV + BOC (From Wk 4) for 44 Wks (Part I)	PEG + RBV + BOC for 48 Wks (Part II)	PEG +Low-dose RBV + BOC for 48 Wks (Part II)	PEG + RBV + BOC (From Wk 24) for 48 Wks (Part I)
Total, serious adverse events
# participants affected / at risk	8/104 (7.69%)	10/107 (9.35%)	8/103 (7.77%)	10/103 (9.71%)	6/103 (5.83%)	1/16 (6.25%)	3/59 (5.08%)	2/36 (5.56%)
Blood and lymphatic system disorders
ANAEMIA ^†
# participants affected / at risk	0/104 (0.00%)	1/107 (0.93%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	1/59 (1.69%)	0/36 (0.00%)
# events	0	1	0	0	0	0	1	0
NEUTROPENIA ^†
# participants affected / at risk	0/104 (0.00%)	2/107 (1.87%)	1/103 (0.97%)	0/103 (0.00%)	0/103 (0.00%)	1/16 (6.25%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	2	1	0	0	1	0	0
Cardiac disorders
PERICARDITIS ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	1/103 (0.97%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	0	0	1	0	0	0
SUPRAVENTRICULAR TACHYCARDIA ^†
# participants affected / at risk	0/104 (0.00%)	1/107 (0.93%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	1	0	0	0	0	0	0
Ear and labyrinth disorders
DEAFNESS UNILATERAL ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	0/103 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	0	1	0	0	0	0
Eye disorders
DIPLOPIA ^†
# participants affected / at risk	1/104 (0.96%)	0/107 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	1	0	0	0	0	0	0	0
RETINAL ISCHAEMIA ^†
# participants affected / at risk	0/104 (0.00%)	1/107 (0.93%)	0/103 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	1	0	1	0	0	0	0
RETINOPATHY ^†
# participants affected / at risk	0/104 (0.00%)	1/107 (0.93%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	1	0	0	0	0	0	0
SCOTOMA ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	0/103 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	0	1	0	0	0	0
Gastrointestinal disorders
ABDOMINAL PAIN ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	1/103 (0.97%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	0	0	1	0	0	0
ABDOMINAL PAIN UPPER ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	1/103 (0.97%)	1/103 (0.97%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	1	1	0	0	0	0
HAEMATEMESIS ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	1/59 (1.69%)	0/36 (0.00%)
# events	0	0	0	0	0	0	1	0
INGUINAL HERNIA ^†
# participants affected / at risk	1/104 (0.96%)	0/107 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	1	0	0	0	0	0	0	0
NAUSEA ^†
# participants affected / at risk	0/104 (0.00%)	2/107 (1.87%)	0/103 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	2	0	1	0	0	0	0
PANCREATITIS ^†
# participants affected / at risk	0/104 (0.00%)	1/107 (0.93%)	0/103 (0.00%)	0/103 (0.00%)	2/103 (1.94%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	1	0	0	7	0	0	0
PERIODONTAL DISEASE ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	0/103 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	0	1	0	0	0	0
PERITONEAL HAEMORRHAGE ^†
# participants affected / at risk	0/104 (0.00%)	1/107 (0.93%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	1	0	0	0	0	0	0
VOMITING ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	1/36 (2.78%)
# events	0	0	1	0	0	0	0	1
General disorders
ASTHENIA ^†
# participants affected / at risk	0/104 (0.00%)	2/107 (1.87%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	2	0	0	0	0	0	0
CHEST PAIN ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	1/59 (1.69%)	0/36 (0.00%)
# events	0	0	0	0	0	0	1	0
FATIGUE ^†
# participants affected / at risk	0/104 (0.00%)	1/107 (0.93%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	1	0	0	0	0	0	0
LOCAL SWELLING ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	1/59 (1.69%)	0/36 (0.00%)
# events	0	0	0	0	0	0	1	0
MULTI-ORGAN FAILURE ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	1	0	0	0	0	0
PYREXIA ^†
# participants affected / at risk	0/104 (0.00%)	1/107 (0.93%)	0/103 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	1	0	1	0	0	0	0
Infections and infestations
CELLULITIS ^†
# participants affected / at risk	0/104 (0.00%)	1/107 (0.93%)	0/103 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	1	0	1	0	0	0	0
CORNEAL INFECTION ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	0/103 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	0	1	0	0	0	0
ERYSIPELAS ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	1	0	0	0	0	0
GASTROENTERITIS ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	1	0	0	0	0	0
LOBAR PNEUMONIA ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	1/16 (6.25%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	0	0	0	1	0	0
PNEUMONIA ^†
# participants affected / at risk	0/104 (0.00%)	1/107 (0.93%)	0/103 (0.00%)	0/103 (0.00%)	1/103 (0.97%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	1	0	0	1	0	0	0
PNEUMONIA STREPTOCOCCAL ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	1	0	0	0	0	0
STAPHYLOCOCCAL SEPSIS ^†
# participants affected / at risk	1/104 (0.96%)	0/107 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	1	0	0	0	0	0	0	0
VULVAL ABSCESS ^†
# participants affected / at risk	0/104 (0.00%)	1/107 (0.93%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	1	0	0	0	0	0	0
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	0/103 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	0	1	0	0	0	0
ANIMAL BITE ^†
# participants affected / at risk	1/104 (0.96%)	0/107 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	1	0	0	0	0	0	0	0
CONTUSION ^†
# participants affected / at risk	1/104 (0.96%)	0/107 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	1	0	0	0	0	0	0	0
DRUG TOXICITY ^†
# participants affected / at risk	0/104 (0.00%)	1/107 (0.93%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	1	0	0	0	0	0	0
FALL ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	1/103 (0.97%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	0	0	1	0	0	0
HAND FRACTURE ^†
# participants affected / at risk	1/104 (0.96%)	0/107 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	1	0	0	0	0	0	0	0
RIB FRACTURE ^†
# participants affected / at risk	1/104 (0.96%)	0/107 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	1	0	0	0	0	0	0	0
Investigations
BLOOD AMYLASE INCREASED ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	1/103 (0.97%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	0	0	1	0	0	0
LIPASE INCREASED ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	1/103 (0.97%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	0	0	1	0	0	0
NEUTROPHIL COUNT DECREASED ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	0/103 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	0	1	0	0	0	0
Metabolism and nutrition disorders
DECREASED APPETITE ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	0/103 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	0	1	0	0	0	0
DEHYDRATION ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	1	0	0	0	0	0
HYPOVOLAEMIA ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	1	0	0	0	0	0
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	1/59 (1.69%)	0/36 (0.00%)
# events	0	0	0	0	0	0	1	0
MUSCLE SPASMS ^†
# participants affected / at risk	1/104 (0.96%)	0/107 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	1	0	0	0	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	0/103 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	0	2	0	0	0	0
BREAST CANCER ^†
# participants affected / at risk	1/104 (0.96%)	0/107 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	1	0	0	0	0	0	0	0
CERVIX CARCINOMA ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	1	0	0	0	0	0
PARATHYROID TUMOUR BENIGN ^†
# participants affected / at risk	1/104 (0.96%)	0/107 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	1	0	0	0	0	0	0	0
RENAL CELL CARCINOMA ^†
# participants affected / at risk	0/104 (0.00%)	1/107 (0.93%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	1	0	0	0	0	0	0
Nervous system disorders
CEREBROVASCULAR ACCIDENT ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	1	0	0	0	0	0
CERVICAL CORD COMPRESSION ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	1/59 (1.69%)	0/36 (0.00%)
# events	0	0	0	0	0	0	1	0
HEADACHE ^†
# participants affected / at risk	0/104 (0.00%)	1/107 (0.93%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	1	0	0	0	0	0	0
HYPOAESTHESIA ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	1	0	0	0	0	0
IIIRD NERVE PARALYSIS ^†
# participants affected / at risk	1/104 (0.96%)	0/107 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	1	0	0	0	0	0	0	0
NEUROPATHY PERIPHERAL ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	1	0	0	0	0	0
PARAESTHESIA ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	1	0	0	0	0	0
Psychiatric disorders
AGGRESSION ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	0/103 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	0	1	0	0	0	0
ALCOHOLISM ^†
# participants affected / at risk	1/104 (0.96%)	0/107 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	1	0	0	0	0	0	0	0
ANXIETY ^†
# participants affected / at risk	0/104 (0.00%)	1/107 (0.93%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	2	0	0	0	0	0	0
DEPENDENCE ^†
# participants affected / at risk	1/104 (0.96%)	0/107 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	1	0	0	0	0	0	0	0
DEPRESSION ^†
# participants affected / at risk	0/104 (0.00%)	1/107 (0.93%)	0/103 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	1	0	1	0	0	0	0
HOMICIDAL IDEATION ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	1/103 (0.97%)	1/103 (0.97%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	1	1	0	0	0	0
PANIC ATTACK ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	1/103 (0.97%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	0	0	1	0	0	0
PARANOIA ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	0/103 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	0	1	0	0	0	0
SUICIDAL IDEATION ^†
# participants affected / at risk	1/104 (0.96%)	1/107 (0.93%)	1/103 (0.97%)	1/103 (0.97%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	1	1	1	1	0	0	0	0
SUICIDE ATTEMPT ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	0/103 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	0	1	0	0	0	0
Respiratory, thoracic and mediastinal disorders
DYSPNOEA ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	0/103 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	0	1	0	0	0	0
PULMONARY EMBOLISM ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	0/103 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	0	1	0	0	0	0
Skin and subcutaneous tissue disorders
URTICARIA ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	1/59 (1.69%)	0/36 (0.00%)
# events	0	0	0	0	0	0	1	0
Surgical and medical procedures
UMBILICAL HERNIA REPAIR ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	1/36 (2.78%)
# events	0	0	0	0	0	0	0	1
Vascular disorders
DEEP VEIN THROMBOSIS ^†
# participants affected / at risk	0/104 (0.00%)	0/107 (0.00%)	0/103 (0.00%)	1/103 (0.97%)	0/103 (0.00%)	0/16 (0.00%)	0/59 (0.00%)	0/36 (0.00%)
# events	0	0	0	1	0	0	0	0

†	Events were collected by systematic assessment

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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 agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The Principal Investigator agrees to provide to the sponsor thirty (30) days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication (including slides and texts of oral or other public presentations and texts of any transmission through any electronic media) that report any results of the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck, Sharp and Dohme
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided by Merck

Publications automatically indexed to this study:

Kwo PY, Lawitz EJ, McCone J, Schiff ER, Vierling JM, Pound D, Davis MN, Galati JS, Gordon SC, Ravendhran N, Rossaro L, Anderson FH, Jacobson IM, Rubin R, Koury K, Pedicone LD, Brass CA, Chaudhri E, Albrecht JK. Efficacy of boceprevir, an NS3 protease inhibitor, in combination with peginterferon alfa-2b and ribavirin in treatment-naive patients with genotype 1 hepatitis C infection (SPRINT-1): an open-label, randomised, multicentre phase 2 trial. Lancet. 2010 Aug 28;376(9742):705-16. Epub 2010 Aug 6.

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme
ClinicalTrials.gov Identifier:	NCT00423670 History of Changes
Other Study ID Numbers:	P03523, EudraCT No. 2006-002543-92
Study First Received:	January 17, 2007
Results First Received:	May 13, 2011
Last Updated:	March 15, 2013
Health Authority:	United States: Food and Drug Administration

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