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Trial record 44 of 50 for:    BI 201335 OR faldaprevir

BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3

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ClinicalTrials.gov Identifier: NCT01830127
Recruitment Status : Completed
First Posted : April 12, 2013
Results First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Drug: Ribavirin
Drug: BI 207127 high dose
Drug: Faldaprevir
Drug: BI 207127 low dose
Enrollment 35
Recruitment Details 35 patients were enrolled and treated with Deleobuvir (DBV) / Faldaprevir (FDV) / Ribavirin (RBV): 18 patients with Child-Pugh A (mild hepatic impairment) and 17 patients with Child-Pugh B (moderate hepatic impairment).
Pre-assignment Details This was phase IIb open label study of BI 207127 (Deleobuvir) in combination with faldaprevir and ribavirin in patients with mild hepatic impairment (Child-Pugh A) and moderate hepatic impairment (Child-Pugh B) with genotype 1b chronic hepatitis C infection.
Arm/Group Title Arm1: Child-Pugh A Arm2: Child-Pugh B
Hide Arm/Group Description Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks. Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
Period Title: Overall Study
Started 18 17
Completed 13 8
Not Completed 5 9
Reason Not Completed
Adverse Event             1             6
Lack of Efficacy             3             0
Withdrawal by Subject             1             1
Other reason not defined above             0             2
Arm/Group Title Arm1: Child-Pugh A Arm2: Child-Pugh B Total
Hide Arm/Group Description Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks. Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 18 17 35
Hide Baseline Analysis Population Description
(Treated Set) All patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomization.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 17 participants 35 participants
57.8  (8.8) 56.6  (9.7) 57.2  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 35 participants
Female
8
  44.4%
7
  41.2%
15
  42.9%
Male
10
  55.6%
10
  58.8%
20
  57.1%
1.Primary Outcome
Title SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT)
Hide Description Sustained virologic response (SVR) at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL(international units per millilitre) at 12 weeks after EOT. SVR12 was analyzed in a descriptive manner using percentage.
Time Frame 12 weeks after End of Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
(Treated Set) All patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomization.
Arm/Group Title Arm1: Child-Pugh A Arm2: Child-Pugh B
Hide Arm/Group Description:
Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
Overall Number of Participants Analyzed 18 17
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
61.1
(38.6 to 83.6)
52.9
(29.2 to 76.7)
2.Secondary Outcome
Title SVR4: Plasma HCV RNA Level Less Than 25 IU/mL at 4 Weeks After End of Treatment (EOT)
Hide Description Sustained virologic response (SVR) at Week 4 post-treatment (SVR4): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL at 4 weeks after EOT. SVR4 was analyzed in a descriptive manner using percentage.
Time Frame 4 weeks after End of Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
(Treated Set) All patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomization.
Arm/Group Title Arm1: Child-Pugh A Arm2: Child-Pugh B
Hide Arm/Group Description:
Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
Overall Number of Participants Analyzed 18 17
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
72.2
(51.5 to 92.9)
76.5
(56.3 to 96.6)
Time Frame From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm1: Child-Pugh A Arm2: Child-Pugh B
Hide Arm/Group Description Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks. Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
All-Cause Mortality
Arm1: Child-Pugh A Arm2: Child-Pugh B
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm1: Child-Pugh A Arm2: Child-Pugh B
Affected / at Risk (%) Affected / at Risk (%)
Total   1/18 (5.56%)   9/17 (52.94%) 
Blood and lymphatic system disorders     
Anaemia  1  0/18 (0.00%)  1/17 (5.88%) 
Gastrointestinal disorders     
Ascites  1  0/18 (0.00%)  1/17 (5.88%) 
Diarrhoea  1  0/18 (0.00%)  1/17 (5.88%) 
Lower gastrointestinal haemorrhage  1  0/18 (0.00%)  1/17 (5.88%) 
Oesophageal varices haemorrhage  1  0/18 (0.00%)  1/17 (5.88%) 
Upper gastrointestinal haemorrhage  1  1/18 (5.56%)  1/17 (5.88%) 
Varices oesophageal  1  0/18 (0.00%)  1/17 (5.88%) 
Vomiting  1  0/18 (0.00%)  1/17 (5.88%) 
General disorders     
General physical health deterioration  1  0/18 (0.00%)  1/17 (5.88%) 
Hepatobiliary disorders     
Acute hepatic failure  1  0/18 (0.00%)  1/17 (5.88%) 
Hepatic cirrhosis  1  0/18 (0.00%)  3/17 (17.65%) 
Infections and infestations     
Peritonitis bacterial  1  0/18 (0.00%)  1/17 (5.88%) 
Urinary tract infection  1  0/18 (0.00%)  1/17 (5.88%) 
Injury, poisoning and procedural complications     
Toxicity to various agents  1  0/18 (0.00%)  1/17 (5.88%) 
Metabolism and nutrition disorders     
Hyponatraemia  1  0/18 (0.00%)  1/17 (5.88%) 
Nervous system disorders     
Hepatic encephalopathy  1  0/18 (0.00%)  4/17 (23.53%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm1: Child-Pugh A Arm2: Child-Pugh B
Affected / at Risk (%) Affected / at Risk (%)
Total   17/18 (94.44%)   17/17 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  6/18 (33.33%)  8/17 (47.06%) 
Lymphopenia  1  1/18 (5.56%)  1/17 (5.88%) 
Thrombocytopenia  1  0/18 (0.00%)  1/17 (5.88%) 
Cardiac disorders     
Bradycardia  1  1/18 (5.56%)  0/17 (0.00%) 
Palpitations  1  1/18 (5.56%)  0/17 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  1/18 (5.56%)  0/17 (0.00%) 
Eye disorders     
Dry eye  1  1/18 (5.56%)  0/17 (0.00%) 
Erythema of eyelid  1  1/18 (5.56%)  0/17 (0.00%) 
Ocular icterus  1  6/18 (33.33%)  3/17 (17.65%) 
Photophobia  1  1/18 (5.56%)  0/17 (0.00%) 
Gastrointestinal disorders     
Abdominal distension  1  5/18 (27.78%)  1/17 (5.88%) 
Abdominal pain  1  2/18 (11.11%)  2/17 (11.76%) 
Abdominal pain upper  1  2/18 (11.11%)  3/17 (17.65%) 
Aphthous stomatitis  1  1/18 (5.56%)  0/17 (0.00%) 
Ascites  1  0/18 (0.00%)  7/17 (41.18%) 
Cheilitis  1  2/18 (11.11%)  0/17 (0.00%) 
Constipation  1  1/18 (5.56%)  3/17 (17.65%) 
Diarrhoea  1  9/18 (50.00%)  9/17 (52.94%) 
Dry mouth  1  0/18 (0.00%)  1/17 (5.88%) 
Dyspepsia  1  2/18 (11.11%)  2/17 (11.76%) 
Faeces soft  1  1/18 (5.56%)  0/17 (0.00%) 
Flatulence  1  1/18 (5.56%)  1/17 (5.88%) 
Gastrooesophageal reflux disease  1  1/18 (5.56%)  2/17 (11.76%) 
Hiatus hernia  1  1/18 (5.56%)  0/17 (0.00%) 
Melaena  1  0/18 (0.00%)  1/17 (5.88%) 
Nausea  1  13/18 (72.22%)  13/17 (76.47%) 
Portal hypertensive gastropathy  1  1/18 (5.56%)  0/17 (0.00%) 
Varices oesophageal  1  0/18 (0.00%)  1/17 (5.88%) 
Vomiting  1  9/18 (50.00%)  6/17 (35.29%) 
General disorders     
Asthenia  1  7/18 (38.89%)  7/17 (41.18%) 
Chills  1  1/18 (5.56%)  0/17 (0.00%) 
Fatigue  1  4/18 (22.22%)  3/17 (17.65%) 
Gait disturbance  1  1/18 (5.56%)  2/17 (11.76%) 
Mucosal dryness  1  1/18 (5.56%)  0/17 (0.00%) 
Oedema  1  0/18 (0.00%)  2/17 (11.76%) 
Oedema peripheral  1  4/18 (22.22%)  5/17 (29.41%) 
Pyrexia  1  0/18 (0.00%)  2/17 (11.76%) 
Hepatobiliary disorders     
Bile duct stone  1  0/18 (0.00%)  1/17 (5.88%) 
Gallbladder disorder  1  1/18 (5.56%)  0/17 (0.00%) 
Hepatomegaly  1  0/18 (0.00%)  1/17 (5.88%) 
Hyperbilirubinaemia  1  8/18 (44.44%)  4/17 (23.53%) 
Jaundice  1  5/18 (27.78%)  8/17 (47.06%) 
Infections and infestations     
Bronchitis  1  1/18 (5.56%)  0/17 (0.00%) 
Gingivitis  1  1/18 (5.56%)  0/17 (0.00%) 
Infective exacerbation of bronchiectasis  1  0/18 (0.00%)  1/17 (5.88%) 
Nasopharyngitis  1  1/18 (5.56%)  0/17 (0.00%) 
Oral candidiasis  1  1/18 (5.56%)  0/17 (0.00%) 
Upper respiratory tract infection  1  1/18 (5.56%)  0/17 (0.00%) 
Urinary tract infection  1  0/18 (0.00%)  3/17 (17.65%) 
Injury, poisoning and procedural complications     
Contusion  1  1/18 (5.56%)  0/17 (0.00%) 
Fall  1  1/18 (5.56%)  0/17 (0.00%) 
Injury  1  2/18 (11.11%)  0/17 (0.00%) 
Limb injury  1  1/18 (5.56%)  0/17 (0.00%) 
Muscle injury  1  1/18 (5.56%)  0/17 (0.00%) 
Wound  1  1/18 (5.56%)  0/17 (0.00%) 
Investigations     
Electrocardiogram QT prolonged  1  2/18 (11.11%)  0/17 (0.00%) 
Glomerular filtration rate decreased  1  0/18 (0.00%)  1/17 (5.88%) 
Hepatic enzyme increased  1  1/18 (5.56%)  0/17 (0.00%) 
Hepatitis C RNA increased  1  1/18 (5.56%)  0/17 (0.00%) 
Lipase increased  1  0/18 (0.00%)  1/17 (5.88%) 
Liver function test abnormal  1  0/18 (0.00%)  1/17 (5.88%) 
Waist circumference increased  1  1/18 (5.56%)  0/17 (0.00%) 
Weight decreased  1  1/18 (5.56%)  1/17 (5.88%) 
Weight increased  1  0/18 (0.00%)  3/17 (17.65%) 
Metabolism and nutrition disorders     
Decreased appetite  1  5/18 (27.78%)  2/17 (11.76%) 
Hyperglycaemia  1  1/18 (5.56%)  0/17 (0.00%) 
Hypernatraemia  1  0/18 (0.00%)  1/17 (5.88%) 
Hypertriglyceridaemia  1  1/18 (5.56%)  0/17 (0.00%) 
Hyperuricaemia  1  1/18 (5.56%)  0/17 (0.00%) 
Hypoalbuminaemia  1  0/18 (0.00%)  2/17 (11.76%) 
Hypocalcaemia  1  0/18 (0.00%)  2/17 (11.76%) 
Hypoglycaemia  1  0/18 (0.00%)  1/17 (5.88%) 
Hypokalaemia  1  0/18 (0.00%)  3/17 (17.65%) 
Hyponatraemia  1  0/18 (0.00%)  1/17 (5.88%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/18 (5.56%)  0/17 (0.00%) 
Back pain  1  1/18 (5.56%)  0/17 (0.00%) 
Monarthritis  1  1/18 (5.56%)  0/17 (0.00%) 
Muscle spasms  1  1/18 (5.56%)  1/17 (5.88%) 
Muscle tightness  1  1/18 (5.56%)  0/17 (0.00%) 
Nervous system disorders     
Burning sensation  1  0/18 (0.00%)  1/17 (5.88%) 
Disturbance in attention  1  1/18 (5.56%)  1/17 (5.88%) 
Dizziness  1  1/18 (5.56%)  5/17 (29.41%) 
Dysgeusia  1  2/18 (11.11%)  1/17 (5.88%) 
Encephalopathy  1  0/18 (0.00%)  1/17 (5.88%) 
Headache  1  1/18 (5.56%)  2/17 (11.76%) 
Hepatic encephalopathy  1  0/18 (0.00%)  1/17 (5.88%) 
Hyperaesthesia  1  1/18 (5.56%)  0/17 (0.00%) 
Hypertonia  1  1/18 (5.56%)  0/17 (0.00%) 
Memory impairment  1  0/18 (0.00%)  1/17 (5.88%) 
Migraine  1  0/18 (0.00%)  1/17 (5.88%) 
Paraesthesia  1  2/18 (11.11%)  1/17 (5.88%) 
Parosmia  1  0/18 (0.00%)  1/17 (5.88%) 
Presyncope  1  0/18 (0.00%)  1/17 (5.88%) 
Restless legs syndrome  1  1/18 (5.56%)  0/17 (0.00%) 
Sensory loss  1  1/18 (5.56%)  0/17 (0.00%) 
Somnolence  1  0/18 (0.00%)  1/17 (5.88%) 
Syncope  1  1/18 (5.56%)  0/17 (0.00%) 
Tremor  1  0/18 (0.00%)  1/17 (5.88%) 
Psychiatric disorders     
Anxiety  1  1/18 (5.56%)  0/17 (0.00%) 
Bradyphrenia  1  0/18 (0.00%)  2/17 (11.76%) 
Depressed mood  1  2/18 (11.11%)  0/17 (0.00%) 
Depression  1  1/18 (5.56%)  0/17 (0.00%) 
Disorientation  1  0/18 (0.00%)  2/17 (11.76%) 
Insomnia  1  3/18 (16.67%)  4/17 (23.53%) 
Libido increased  1  1/18 (5.56%)  0/17 (0.00%) 
Nightmare  1  0/18 (0.00%)  1/17 (5.88%) 
Renal and urinary disorders     
Chromaturia  1  2/18 (11.11%)  0/17 (0.00%) 
Proteinuria  1  0/18 (0.00%)  1/17 (5.88%) 
Renal colic  1  1/18 (5.56%)  0/17 (0.00%) 
Renal failure  1  0/18 (0.00%)  2/17 (11.76%) 
Reproductive system and breast disorders     
Amenorrhoea  1  0/18 (0.00%)  1/17 (5.88%) 
Breast pain  1  0/18 (0.00%)  1/17 (5.88%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/18 (0.00%)  3/17 (17.65%) 
Dyspnoea  1  2/18 (11.11%)  1/17 (5.88%) 
Dyspnoea exertional  1  1/18 (5.56%)  1/17 (5.88%) 
Nasal dryness  1  1/18 (5.56%)  0/17 (0.00%) 
Oropharyngeal pain  1  1/18 (5.56%)  0/17 (0.00%) 
Skin and subcutaneous tissue disorders     
Blister  1  2/18 (11.11%)  0/17 (0.00%) 
Dry skin  1  2/18 (11.11%)  1/17 (5.88%) 
Eczema  1  1/18 (5.56%)  1/17 (5.88%) 
Erythema  1  3/18 (16.67%)  2/17 (11.76%) 
Hyperhidrosis  1  1/18 (5.56%)  0/17 (0.00%) 
Night sweats  1  1/18 (5.56%)  0/17 (0.00%) 
Onychalgia  1  0/18 (0.00%)  1/17 (5.88%) 
Photosensitivity reaction  1  3/18 (16.67%)  1/17 (5.88%) 
Pruritus  1  8/18 (44.44%)  5/17 (29.41%) 
Pruritus generalised  1  1/18 (5.56%)  0/17 (0.00%) 
Rash  1  3/18 (16.67%)  1/17 (5.88%) 
Rash maculo-papular  1  0/18 (0.00%)  2/17 (11.76%) 
Rash papular  1  1/18 (5.56%)  0/17 (0.00%) 
Skin exfoliation  1  1/18 (5.56%)  0/17 (0.00%) 
Urticaria  1  1/18 (5.56%)  0/17 (0.00%) 
Surgical and medical procedures     
Tooth extraction  1  1/18 (5.56%)  0/17 (0.00%) 
Vascular disorders     
Hypotension  1  0/18 (0.00%)  1/17 (5.88%) 
Vasospasm  1  1/18 (5.56%)  0/17 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Because the company decided to stop the DBV development program, analyses for this trial were limited to the basic requirement for efficacy, and only the primary endpoint and secondary endpoint were analyzed.
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.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights.
Results Point of Contact
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01830127     History of Changes
Other Study ID Numbers: 1241.30
2012-003534-17 ( EudraCT Number: EudraCT )
First Submitted: March 22, 2013
First Posted: April 12, 2013
Results First Submitted: October 20, 2015
Results First Posted: November 20, 2015
Last Update Posted: November 20, 2015