Trial Outcomes & Findings for Open-Label Safety Study of Telaprevir and Sofosbuvir in Chronic Hepatitis C Genotype 1 (NCT NCT01994486)
NCT ID: NCT01994486
Last Updated: 2018-04-23
Results Overview
Study drug adherence and adverse events were collected on all enrolled subjects and graded using the DAIDS scale. Any adverse events leading to discontinuation of both Telaprevir and Sofosbuvir were collected and are hereby reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
12 weeks-January 3, 2014- April 10, 2014
Results posted on
2018-04-23
Participant Flow
Participant milestones
| Measure |
Telaprevir and Sofosbuvir
All subjects will receive Telaprevir 1125 mg capsule twice a day with Sofosbuvir 400 mg capsule once daily for 12 weeks.
In addition, sparse PK samples will be collected at week 2 and week 10.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open-Label Safety Study of Telaprevir and Sofosbuvir in Chronic Hepatitis C Genotype 1
Baseline characteristics by cohort
| Measure |
Telaprevir and Sofosbuvir
n=20 Participants
All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks.
Telaprevir and Sofosbuvir: All subjects will have an ECG performed. Then they will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks. In addition, PK samples will be collected at week 2 and week 10.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
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17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
51 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks-January 3, 2014- April 10, 2014Population: Non-cirrhotic Hepatitis C Genotype 1 infected subjects, naive to previous Hepatitis C treatment
Study drug adherence and adverse events were collected on all enrolled subjects and graded using the DAIDS scale. Any adverse events leading to discontinuation of both Telaprevir and Sofosbuvir were collected and are hereby reported.
Outcome measures
| Measure |
Telaprevir and Sofosbuvir
n=20 Participants
All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily for 12 weeks.
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|---|---|
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Frequency of Adverse Events Leading to Discontinuation of Both Telaprevir and Sofosbuvir Among Subjects Treated With Telaprevir and Sofosbuvir
|
0 participants
|
PRIMARY outcome
Timeframe: 1/3/2014-4/10/2014The number of subjects who experienced Grade 3 anemia. Complete blood count was collected at baseline, week 2, week 4, week 8, week 12, week 18, and week 24. Incidence of moderate anemia (Grade 3) observed in the study treatment period.
Outcome measures
| Measure |
Telaprevir and Sofosbuvir
n=20 Participants
All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily for 12 weeks.
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|---|---|
|
Safety of Telaprevir and Sofosbuvir When Dosed in Combination for 12 Weeks
|
1 participants
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SECONDARY outcome
Timeframe: 1/17/2014-3/26/2014Sparse Pharmokinetic blood samples were collected at Week 2 and Week 10 (prior to daily dose) in patients treated with Telaprevir and Sofosbuvir.
Outcome measures
| Measure |
Telaprevir and Sofosbuvir
n=20 Participants
All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily for 12 weeks.
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|---|---|
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Characterize Steady State of Sofosbuvir Active SOF Metabolite, GS-331007
Pre-Dose Trough Level Metabolite GS-331007 Wk 2
|
593 ng/mL
Standard Deviation 181
|
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Characterize Steady State of Sofosbuvir Active SOF Metabolite, GS-331007
Pre-Dose Trough Level GS-331007 Wk 10
|
619 ng/mL
Standard Deviation 216
|
SECONDARY outcome
Timeframe: 6/16/2014-7/2/2014Plasma HCV RNA levels were assessed using the COBAS TaqMan HCV RNA assay test (v2.0; Roche Diagnostics, Indianapolis, IN, USA; LLOQ=25 IU/mL;limit of detection =15 IU/mL)
Outcome measures
| Measure |
Telaprevir and Sofosbuvir
n=20 Participants
All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily for 12 weeks.
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|---|---|
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Proportion of Subjects Who Achieve Undetectable Hepatitis C Virus RNA at 12 Weeks After Completing Study Drug Regimen
|
19 participants
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SECONDARY outcome
Timeframe: 1/3/2014-9/8/2014Defined as Subjects who have undetectable HCV RNA at end of treatment, and confirmed detectable HCV RNA between end of treatment and SVR12 planned assessment time point.
Outcome measures
| Measure |
Telaprevir and Sofosbuvir
n=20 Participants
All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily for 12 weeks.
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|---|---|
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Proportion of Subjects With Viral Relapse
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1 participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: 4/22/2014-5/6/2014Subjects who complete assigned treatment and have undetectable HCV RNA at 12 weeks after the last planned dose of study treatment
Outcome measures
| Measure |
Telaprevir and Sofosbuvir
n=20 Participants
All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily for 12 weeks.
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|---|---|
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Number of Subjects With Sustained Virologic Response at 4 Weeks After Completion of Last Dose
|
19 participants
|
Adverse Events
Telaprevir and Sofosbuvir
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Telaprevir and Sofosbuvir
n=20 participants at risk
All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily for 12 weeks.
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|---|---|
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Cardiac disorders
Bradycardia
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
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Other adverse events
| Measure |
Telaprevir and Sofosbuvir
n=20 participants at risk
All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily for 12 weeks.
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|---|---|
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Gastrointestinal disorders
Abdominal bloating
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Gastrointestinal disorders
Abdominal cramps
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
2/20 • Number of events 2 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.0%
3/20 • Number of events 3 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Gastrointestinal disorders
Anorectal_symptoms
|
30.0%
6/20 • Number of events 6 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Metabolism and nutrition disorders
Anorexia
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Skin and subcutaneous tissue disorders
Blister
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Investigations
Blood creatinine increased
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
General disorders
Chills
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
4/20 • Number of events 4 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Psychiatric disorders
Depression
|
10.0%
2/20 • Number of events 2 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
2/20 • Number of events 2 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Nervous system disorders
Dysgeusia
|
10.0%
2/20 • Number of events 2 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
General disorders
Fatigue
|
20.0%
4/20 • Number of events 4 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Vascular disorders
Flushing
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
General disorders
Gait disturbance
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Infections and infestations
Head cold
|
10.0%
2/20 • Number of events 3 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Nervous system disorders
Head pressure
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Nervous system disorders
Headache
|
30.0%
6/20 • Number of events 6 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Gastrointestinal disorders
Hemorrhoids
|
10.0%
2/20 • Number of events 2 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Musculoskeletal and connective tissue disorders
Herniated disc
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Psychiatric disorders
Hyperactivity
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Gastrointestinal disorders
Increased frequency of bowel movements
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
General disorders
Induration
|
10.0%
2/20 • Number of events 3 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
General disorders
Irritability
|
10.0%
2/20 • Number of events 2 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Nervous system disorders
Lightheadedness
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Gastrointestinal disorders
Lip swelling
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Gastrointestinal disorders
Loose stools
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Gastrointestinal disorders
Nausea
|
45.0%
9/20 • Number of events 9 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
General disorders
Peripheral edema
|
10.0%
2/20 • Number of events 2 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
5/20 • Number of events 5 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Skin and subcutaneous tissue disorders
Rash
|
40.0%
8/20 • Number of events 8 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Gastrointestinal disorders
Regurgitation
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Musculoskeletal and connective tissue disorders
Rib pain
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Infections and infestations
Sinusitis
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Nervous system disorders
Tingling
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Ear and labyrinth disorders
Tinnitus
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Infections and infestations
Tooth abscess
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Infections and infestations
Upper respiratory infection
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Ear and labyrinth disorders
Vertigo
|
5.0%
1/20 • Number of events 1 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
3/20 • Number of events 3 • 24 weeks
AEs collected from all subjects beginning at baseline through 28 days after last dose of study medication were assigned to treatment phase for evaluation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place