Open-Label Study of Sofusbuvir+Ribavirin With or Without... | NCT01625338

NCT01625338

ID	Type	Description	Link
2012-000571-16	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SOF+RBV 12 Weeks	Experimental	SOF+RBV for 12 weeks	Drug: SOF Drug: RBV
SOF+RBV 24 Weeks	Experimental	SOF+RBV for 24 weeks	Drug: SOF Drug: RBV
SOF+RBV+Peg-IFN 12 Weeks	Experimental	SOF+RBV+Peg-IFN for 12 weeks	Drug: SOF Drug: RBV Drug: Peg-IFN

Name	Type	Description	Arm Group Labels	Other Names
SOF	Drug	SOF 400 mg tablet administered orally once daily	SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.	Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event		Up to 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.	Posttreatment Weeks 4 and 24
Percentage of Participants With On-treatment Virologic Failure

Eligibility Module

Name	Affiliation	Role
Bittoo Kanwar, MD	Gilead Sciences	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
Franco Felizarta, MD

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	SOF+RBV 12 Weeks	Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
FG001	SOF+RBV 24 Weeks	SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	SOF+RBV 12 Weeks	SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
BG001	SOF+RBV 24 Weeks	SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
BG002	SOF+RBV+Peg-IFN 12 Weeks	SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00053± 9.6 BG00152± 7.6 BG00253± 10.0 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00054 BG00150 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

White

Title	Measurements
	BG000105 BG001184 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Hispanic or Latino

Title	Measurements
	BG00019 BG00112 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00077 BG00182 BG002

HCV Genotype

Number

participants

Title

Denominators

Categories

Genotype 1

Title	Measurements
	BG0000 BG0012 BG002

Cirrhosis Status

Number

participants

Title

Denominators

Categories

Title	Measurements
	BG00089 BG001138 BG002

IL28b Status

CC, CT, and TT alleles are different forms of the IL28b gene.

Number

participants

Title

Denominators

Categories

Title	Measurements
	BG00038 BG00159 BG002

HCV RNA

Mean

Standard Deviation

log10 IU/mL

Title

Denominators

Categories

Title	Measurements
	BG0006.3± 0.87 BG0016.4± 0.70 BG002

HCV RNA Category

Number

participants

Title

Denominators

Categories

< 800,000 IU/mL

Title	Measurements
	BG00030 BG00144 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.

Full Analysis Set: participants who were enrolled and received at least 1 dose of study drug.

Posted

Number

percentage of participants

Posttreatment Week 12

ID	Title	Description
OG000	SOF+RBV 12 Weeks	SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
OG001	SOF+RBV 24 Weeks	SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
OG002	SOF+RBV+Peg-IFN 12 Weeks	SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants

Units	Counts
Participants	OG000114 OG001200 OG002219

Title

Denominators

Categories

Title	Measurements
	OG00071.9 OG00177.5 OG00282.6

Primary

Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.

Posted

Number

percentage of participants

Up to 24 weeks

ID	Title	Description
OG000	SOF+RBV 12 Weeks	SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
OG001	SOF+RBV 24 Weeks	SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
OG002	SOF+RBV+Peg-IFN 12 Weeks	SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants

Units	Counts
Participants

Secondary

Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.

Full Analysis Set

Posted

Number

percentage of participants

Posttreatment Weeks 4 and 24

ID	Title	Description
OG000	SOF+RBV 12 Weeks	SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
OG001	SOF+RBV 24 Weeks	SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
OG002	SOF+RBV+Peg-IFN 12 Weeks	SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants

Units	Counts
Participants

Secondary

Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as

Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)

Full Analysis Set

Posted

Number

percentage of participants

Up to 24 weeks

ID	Title	Description
OG000	SOF+RBV 12 Weeks	SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
OG001	SOF+RBV 24 Weeks	SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
OG002	SOF+RBV+Peg-IFN 12 Weeks	SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants

Units

Secondary

Percentage of Participants With Viral Relapse

Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.

Participants in the Full Analysis Set with available data were analyzed.

Posted

Number

percentage of participants

Up to Posttreatment Week 24

ID	Title	Description
OG000	SOF+RBV 12 Weeks	SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
OG001	SOF+RBV 24 Weeks	SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
OG002	SOF+RBV+Peg-IFN 12 Weeks	SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants

Units	Counts

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	SOF+RBV 12 Weeks	SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks	4	114	92	114
EG001	SOF+RBV 24 Weeks	SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks	11	200	167	200
EG002	SOF+RBV+Peg-IFN 12 Weeks	SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants	4	219	194	219

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA Version 17.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected200 at risk EG0020 affected219 at risk
Dysphagia	Gastrointestinal disorders	MedDRA Version 17.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected200 at risk EG0021 affected219 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA Version 17.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected200 at risk EG0020 affected219 at risk
Meningitis aseptic	Infections and infestations	MedDRA Version 17.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected200 at risk EG0020 affected219 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA Version 17.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected200 at risk EG0020 affected219 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA Version 17.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected200 at risk EG0020 affected219 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 17.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected200 at risk EG0020 affected219 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA Version 17.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected200 at risk EG0020 affected219 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA Version 17.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected200 at risk EG0020 affected219 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 17.1	Systematic Assessment	EG0001 affected114 at risk EG0011 affected200 at risk EG0020 affected219 at risk
Headache	Nervous system disorders	MedDRA Version 17.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected200 at risk EG0020 affected219 at risk
Myelitis transverse	Nervous system disorders	MedDRA Version 17.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected200 at risk EG0020 affected219 at risk
Presyncope	Nervous system disorders	MedDRA Version 17.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected200 at risk EG0020 affected219 at risk
Affective disorder	Psychiatric disorders	MedDRA Version 17.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected200 at risk EG0020 affected219 at risk
Insomnia	Psychiatric disorders	MedDRA Version 17.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected200 at risk EG0020 affected219 at risk
Mania	Psychiatric disorders	MedDRA Version 17.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected200 at risk EG0020 affected219 at risk
Psychotic disorder	Psychiatric disorders	MedDRA Version 17.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected200 at risk EG0020 affected219 at risk
Substance-induced psychotic disorder	Psychiatric disorders	MedDRA Version 17.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected200 at risk EG0021 affected219 at risk
Suicide attempt	Psychiatric disorders	MedDRA Version 17.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected200 at risk EG0021 affected219 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA Version 17.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected200 at risk EG0020 affected219 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 17.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected200 at risk EG0021 affected219 at risk
Social stay hospitalisation	Social circumstances	MedDRA Version 17.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected200 at risk EG0020 affected219 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 17.1	Systematic Assessment	EG00013 affected114 at risk EG00112 affected200 at risk EG00226 affected219 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA Version 17.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected200 at risk EG00211 affected219 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 17.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected200 at risk EG00238 affected219 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Version 17.1	Systematic Assessment	EG0006 affected114 at risk EG0017 affected200 at risk EG0025 affected219 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 17.1	Systematic Assessment	EG0007 affected114 at risk EG00114 affected200 at risk EG00228 affected219 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 17.1	Systematic Assessment	EG00022 affected114 at risk EG00127 affected200 at risk EG00252 affected219 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 17.1	Systematic Assessment	EG0007 affected114 at risk EG0017 affected200 at risk EG0029 affected219 at risk
Asthenia	General disorders	MedDRA Version 17.1	Systematic Assessment	EG0005 affected114 at risk EG0019 affected200 at risk EG00219 affected219 at risk
Chills	General disorders	MedDRA Version 17.1	Systematic Assessment	EG0002 affected114 at risk EG0013 affected200 at risk EG00219 affected219 at risk
Fatigue	General disorders	MedDRA Version 17.1	Systematic Assessment	EG00033 affected114 at risk EG00166 affected200 at risk EG00297 affected219 at risk
Influenza like illness	General disorders	MedDRA Version 17.1	Systematic Assessment	EG0006 affected114 at risk EG0015 affected200 at risk EG00245 affected219 at risk
Pain	General disorders	MedDRA Version 17.1	Systematic Assessment	EG0002 affected114 at risk EG0014 affected200 at risk EG00217 affected219 at risk
Pyrexia	General disorders	MedDRA Version 17.1	Systematic Assessment	EG0005 affected114 at risk EG0011 affected200 at risk EG00227 affected219 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 17.1	Systematic Assessment	EG0009 affected114 at risk EG00122 affected200 at risk EG0024 affected219 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA Version 17.1	Systematic Assessment	EG0007 affected114 at risk EG0019 affected200 at risk EG0022 affected219 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA Version 17.1	Systematic Assessment	EG0003 affected114 at risk EG0018 affected200 at risk EG00232 affected219 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 17.1	Systematic Assessment	EG00013 affected114 at risk EG00121 affected200 at risk EG00237 affected219 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 17.1	Systematic Assessment	EG0009 affected114 at risk EG00111 affected200 at risk EG00213 affected219 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA Version 17.1	Systematic Assessment	EG0007 affected114 at risk EG00117 affected200 at risk EG00211 affected219 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 17.1	Systematic Assessment	EG0008 affected114 at risk EG0019 affected200 at risk EG00245 affected219 at risk
Dizziness	Nervous system disorders	MedDRA Version 17.1	Systematic Assessment	EG0004 affected114 at risk EG00113 affected200 at risk EG00223 affected219 at risk
Dysgeusia	Nervous system disorders	MedDRA Version 17.1	Systematic Assessment	EG0003 affected114 at risk EG0010 affected200 at risk EG00212 affected219 at risk
Headache	Nervous system disorders	MedDRA Version 17.1	Systematic Assessment	EG00015 affected114 at risk EG00157 affected200 at risk EG00271 affected219 at risk
Anxiety	Psychiatric disorders	MedDRA Version 17.1	Systematic Assessment	EG0006 affected114 at risk EG00111 affected200 at risk EG00214 affected219 at risk
Depression	Psychiatric disorders	MedDRA Version 17.1	Systematic Assessment	EG0007 affected114 at risk EG00121 affected200 at risk EG00214 affected219 at risk
Insomnia	Psychiatric disorders	MedDRA Version 17.1	Systematic Assessment	EG00018 affected114 at risk EG00134 affected200 at risk EG00237 affected219 at risk
Irritability	Psychiatric disorders	MedDRA Version 17.1	Systematic Assessment	EG0005 affected114 at risk EG00127 affected200 at risk EG00238 affected219 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 17.1	Systematic Assessment	EG00011 affected114 at risk EG00111 affected200 at risk EG00233 affected219 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 17.1	Systematic Assessment	EG0006 affected114 at risk EG00112 affected200 at risk EG00211 affected219 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA Version 17.1	Systematic Assessment	EG0005 affected114 at risk EG0017 affected200 at risk EG00213 affected219 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 17.1	Systematic Assessment	EG0003 affected114 at risk EG0014 affected200 at risk EG00212 affected219 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA Version 17.1	Systematic Assessment	EG0006 affected114 at risk EG00114 affected200 at risk EG00217 affected219 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 17.1	Systematic Assessment	EG00015 affected114 at risk EG00123 affected200 at risk EG00240 affected219 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 17.1	Systematic Assessment	EG00013 affected114 at risk EG00119 affected200 at risk EG00235 affected219 at risk

Certain Agreements

Ancestor Terms

ID	Term
D006526	Hepatitis C
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human
D014777	Virus Diseases
D018178	Flaviviridae Infections
D012327	RNA Virus Infections
D006521	Hepatitis, Chronic
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D014542	Uridine Monophosphate
D014500	Uracil Nucleotides
D011742	Pyrimidine Nucleotides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D009711	Nucleotides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D012265	Ribonucleotides