Peginterferon Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471AM1)(COMPLETED) - Study Results

Study Type:	Interventional
Study Design:	Randomized, Open Label, Dose Comparison, Parallel Assignment
Condition:	Hepatitis C, Chronic
Interventions:	Biological: PegIntron (peginterferon alfa-2b; SCH 54031) Drug: REBETOL (ribavirin; SCH 18908) Biological: PEGASYS (peginterferon alfa-2a) Drug: COPEGUS (ribavirin)

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrolled 4469 subjects; Randomized 3083; Treated 3070

Reporting Groups

	Description
PegIntron 1.5 ug/kg/wk Plus REBETOL	PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
PegIntron 1.0 ug/kg/wk Plus REBETOL	PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
PEGASYS 180 ug/wk Plus COPEGUS	PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up

Participant Flow: Overall Study

	PegIntron 1.5 ug/kg/wk Plus REBETOL	PegIntron 1.0 ug/kg/wk Plus REBETOL	PEGASYS 180 ug/wk Plus COPEGUS
STARTED	1019	1016	1035
COMPLETED	517^[1]	470^[2]	579^[3]
NOT COMPLETED	502	546	456
Adverse Event	130	98	136
Lack of Efficacy	262	357	211
Lost to Follow-up	45	34	45
Protocol Violation	15	10	10
Withdrawal by Subject	45	40	42
Did not meet protocol eligibility	2	0	3
Administrative	1	0	1
Not Specified	2	7	8

[1]	Patients who discontinued treatment but continued in study are considered Not Completed
[2]	Patients who discontinued treatment but continued in study are considered Not Completed
[3]	Patients who discontinued treatment but continued in study are considered Not Completed

Baseline Characteristics

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Reporting Groups

	Description
PegIntron 1.5 ug/kg/wk Plus REBETOL	PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
PegIntron 1.0 ug/kg/wk Plus REBETOL	PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
PEGASYS 180 ug/wk Plus COPEGUS	PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up

Baseline Measures

	PegIntron 1.5 ug/kg/wk Plus REBETOL	PegIntron 1.0 ug/kg/wk Plus REBETOL	PEGASYS 180 ug/wk Plus COPEGUS	Total
Number of Participants [units: participants]	1019	1016	1035	3070
Age [units: years] Mean ± Standard Deviation	47.5 ± 7.8	47.5 ± 8.1	47.6 ± 8.2	47.5 ± 8.0
Gender [units: participants]
Female	406	409	422	1237
Male	613	607	613	1833

Outcome Measures

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1. Primary:

Sustained Virologic Response (SVR) Rate [ Assessed at the end of a 24-week post-treatment follow-up ]

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2. Secondary:

Mean Change From Baseline in the Log Viral Load at Treatment Week 4 [ Assessed at Baseline and Treatment Week 4 ]

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3. Secondary:

Virologic Response Rate at Treatment Week 12 [ Assessed at Treatment Week 12 ]

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4. Secondary:

Mean Change From Baseline in the Log Viral Load at Treatment Week 2 [ Assessed at Baseline and Treatment Week 2 ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
PegIntron 1.5 ug/kg/wk Plus REBETOL	No text entered.
PegIntron 1.0 ug/kg/wk Plus REBETOL	No text entered.
PEGASYS 180 ug/wk Plus COPEGUS	No text entered.

Other Adverse Events

	PegIntron 1.5 ug/kg/wk Plus REBETOL	PegIntron 1.0 ug/kg/wk Plus REBETOL	PEGASYS 180 ug/wk Plus COPEGUS
Total, other (not including serious) adverse events
# participants affected / at risk	996	1000	1018
Blood and lymphatic system disorders
ANAEMIA ^†^A # participants affected / at risk # events	344/1019 (33.76%) 555	291/1016 (28.64%) 442	348/1035 (33.62%) 556
LEUKOPENIA ^†^A # participants affected / at risk # events	95/1019 (9.32%) 153	69/1016 (6.79%) 109	106/1035 (10.24%) 206
NEUTROPENIA ^†^A # participants affected / at risk # events	263/1019 (25.81%) 466	188/1016 (18.50%) 300	325/1035 (31.40%) 670
THROMBOCYTOPENIA ^†^A # participants affected / at risk # events	29/1019 (2.85%) 38	24/1016 (2.36%) 45	64/1035 (6.18%) 111
Endocrine disorders
HYPOTHYROIDISM ^†^A # participants affected / at risk # events	56/1019 (5.50%) 61	39/1016 (3.84%) 42	48/1035 (4.64%) 51
Eye disorders
VISION BLURRED ^†^A # participants affected / at risk # events	46/1019 (4.51%) 52	62/1016 (6.10%) 69	74/1035 (7.15%) 76
Gastrointestinal disorders
ABDOMINAL PAIN ^†^A # participants affected / at risk # events	47/1019 (4.61%) 59	53/1016 (5.22%) 60	61/1035 (5.89%) 70
ABDOMINAL PAIN UPPER ^†^A # participants affected / at risk # events	51/1019 (5.00%) 60	50/1016 (4.92%) 55	54/1035 (5.22%) 69
CONSTIPATION ^†^A # participants affected / at risk # events	77/1019 (7.56%) 85	83/1016 (8.17%) 89	63/1035 (6.09%) 68
DIARRHOEA ^†^A # participants affected / at risk # events	170/1019 (16.68%) 221	193/1016 (19.00%) 230	173/1035 (16.71%) 207
DRY MOUTH ^†^A # participants affected / at risk # events	58/1019 (5.69%) 60	53/1016 (5.22%) 53	50/1035 (4.83%) 52
DYSPEPSIA ^†^A # participants affected / at risk # events	60/1019 (5.89%) 62	62/1016 (6.10%) 72	69/1035 (6.67%) 78
NAUSEA ^†^A # participants affected / at risk # events	433/1019 (42.49%) 517	377/1016 (37.11%) 462	375/1035 (36.23%) 434
VOMITING ^†^A # participants affected / at risk # events	150/1019 (14.72%) 190	122/1016 (12.01%) 149	119/1035 (11.50%) 141
General disorders
ASTHENIA ^†^A # participants affected / at risk # events	51/1019 (5.00%) 57	44/1016 (4.33%) 48	41/1035 (3.96%) 43
CHILLS ^†^A # participants affected / at risk # events	397/1019 (38.96%) 428	365/1016 (35.93%) 421	243/1035 (23.48%) 266
FATIGUE ^†^A # participants affected / at risk # events	672/1019 (65.95%) 798	676/1016 (66.54%) 802	656/1035 (63.38%) 809
INFLUENZA LIKE ILLNESS ^†^A # participants affected / at risk # events	164/1019 (16.09%) 203	154/1016 (15.16%) 175	160/1035 (15.46%) 182
INJECTION SITE ERYTHEMA ^†^A # participants affected / at risk # events	166/1019 (16.29%) 172	178/1016 (17.52%) 197	123/1035 (11.88%) 125
INJECTION SITE REACTION ^†^A # participants affected / at risk # events	102/1019 (10.01%) 118	112/1016 (11.02%) 116	58/1035 (5.60%) 62
IRRITABILITY ^†^A # participants affected / at risk # events	256/1019 (25.12%) 317	262/1016 (25.79%) 319	262/1035 (25.31%) 314
PAIN ^†^A # participants affected / at risk # events	126/1019 (12.37%) 156	138/1016 (13.58%) 168	100/1035 (9.66%) 124
PYREXIA ^†^A # participants affected / at risk # events	356/1019 (34.94%) 417	331/1016 (32.58%) 381	237/1035 (22.90%) 264
Infections and infestations
BRONCHITIS ^†^A # participants affected / at risk # events	34/1019 (3.34%) 37	32/1016 (3.15%) 39	60/1035 (5.80%) 66
SINUSITIS ^†^A # participants affected / at risk # events	59/1019 (5.79%) 72	43/1016 (4.23%) 53	72/1035 (6.96%) 90
Investigations
WEIGHT DECREASED ^†^A # participants affected / at risk # events	138/1019 (13.54%) 164	105/1016 (10.33%) 122	102/1035 (9.86%) 116
Metabolism and nutrition disorders
ANOREXIA ^†^A # participants affected / at risk # events	121/1019 (11.87%) 131	96/1016 (9.45%) 100	76/1035 (7.34%) 81
DECREASED APPETITE ^†^A # participants affected / at risk # events	184/1019 (18.06%) 197	159/1016 (15.65%) 167	142/1035 (13.72%) 152
Musculoskeletal and connective tissue disorders
ARTHRALGIA ^†^A # participants affected / at risk # events	238/1019 (23.36%) 296	237/1016 (23.33%) 294	250/1035 (24.15%) 307
BACK PAIN ^†^A # participants affected / at risk # events	105/1019 (10.30%) 118	106/1016 (10.43%) 125	120/1035 (11.59%) 136
MUSCLE SPASMS ^†^A # participants affected / at risk # events	53/1019 (5.20%) 64	51/1016 (5.02%) 63	72/1035 (6.96%) 88
MYALGIA ^†^A # participants affected / at risk # events	274/1019 (26.89%) 309	270/1016 (26.57%) 305	233/1035 (22.51%) 263
PAIN IN EXTREMITY ^†^A # participants affected / at risk # events	52/1019 (5.10%) 55	56/1016 (5.51%) 66	74/1035 (7.15%) 105
Nervous system disorders
DISTURBANCE IN ATTENTION ^†^A # participants affected / at risk # events	72/1019 (7.07%) 81	53/1016 (5.22%) 60	71/1035 (6.86%) 81
DIZZINESS ^†^A # participants affected / at risk # events	172/1019 (16.88%) 218	154/1016 (15.16%) 194	145/1035 (14.01%) 171
DYSGEUSIA ^†^A # participants affected / at risk # events	80/1019 (7.85%) 88	73/1016 (7.19%) 76	66/1035 (6.38%) 70
HEADACHE ^†^A # participants affected / at risk # events	508/1019 (49.85%) 646	486/1016 (47.83%) 609	438/1035 (42.32%) 559
Psychiatric disorders
ANXIETY ^†^A # participants affected / at risk # events	114/1019 (11.19%) 142	117/1016 (11.52%) 143	112/1035 (10.82%) 125
DEPRESSION ^†^A # participants affected / at risk # events	259/1019 (25.42%) 351	197/1016 (19.39%) 263	215/1035 (20.77%) 257
INSOMNIA ^†^A # participants affected / at risk # events	401/1019 (39.35%) 482	389/1016 (38.29%) 460	428/1035 (41.35%) 500
Respiratory, thoracic and mediastinal disorders
COUGH ^†^A # participants affected / at risk # events	167/1019 (16.39%) 202	183/1016 (18.01%) 223	210/1035 (20.29%) 256
DYSPNOEA ^†^A # participants affected / at risk # events	176/1019 (17.27%) 200	173/1016 (17.03%) 201	172/1035 (16.62%) 194
DYSPNOEA EXERTIONAL ^†^A # participants affected / at risk # events	55/1019 (5.40%) 58	55/1016 (5.41%) 59	75/1035 (7.25%) 81
PHARYNGOLARYNGEAL PAIN ^†^A # participants affected / at risk # events	63/1019 (6.18%) 69	67/1016 (6.59%) 73	76/1035 (7.34%) 86
Skin and subcutaneous tissue disorders
ALOPECIA ^†^A # participants affected / at risk # events	233/1019 (22.87%) 249	205/1016 (20.18%) 211	176/1035 (17.00%) 178
DRY SKIN ^†^A # participants affected / at risk # events	122/1019 (11.97%) 134	117/1016 (11.52%) 125	137/1035 (13.24%) 162
PRURITUS ^†^A # participants affected / at risk # events	163/1019 (16.00%) 194	138/1016 (13.58%) 168	182/1035 (17.58%) 222
RASH ^†^A # participants affected / at risk # events	225/1019 (22.08%) 289	223/1016 (21.95%) 280	290/1035 (28.02%) 429

^†	Indicates events were collected by systematic assessment.
^A	Term from vocabulary, MedDRA 10.1

More Information

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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.

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: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com

Publications of Results:

McHutchison JG, Lawitz EJ, Shiffman ML, Muir AJ, Galler GW, McCone J, Nyberg LM, Lee WM, Ghalib RH, Schiff ER, Galati JS, Bacon BR, Davis MN, Mukhopadhyay P, Koury K, Noviello S, Pedicone LD, Brass CA, Albrecht JK, Sulkowski MS; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009 Aug 6;361(6):580-93. Epub 2009 Jul 22.

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P03471, 2552898
Study First Received:	April 20, 2004
Results First Received:	November 3, 2008
Last Updated:	September 24, 2009
ClinicalTrials.gov Identifier:	NCT00081770 History of Changes
Health Authority:	United States: Food and Drug Administration