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| ID | Type | Description | Link |
|---|---|---|---|
| TMC435HPC3016 | Other Identifier | Janssen R&D Ireland | |
| 2013-002726-23 | EudraCT Number |
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The purpose of the study is to evaluate effect of steady-state (when the amount of drug administered (in a given time period is equal to the amount of drug eliminated in that same period) of simeprevir and daclatasvir on the steady-state pharmacokinetics (what a medication does to the body) of cyclosporine (applicable to Part 1 only) and tacrolimus when administered as a combinational regimen in post-orthotopic liver transplantation (OLT) participants with recurrent hepatitis C virus (HCV) genotype 1b infection and effectiveness of a 24-week treatment regimen containing simeprevir, daclatasvir, and ribavirin (RBV) with respect to the proportion of HCV genotype 1b infected post-OLT participants achieving sustained virologic response 12 weeks after end of treatment.
This is an open-label (all participants of this study know the identity of the intervention) and multicenter (study conducted at multiple sites) study. This study will be conducted in 2 parts. Both the parts of the study will consist of screening phase (4 weeks), treatment period (24 weeks), and a post-treatment follow-up (24 weeks). A total of 30 participants will be enrolled in Part 1 and Part 2 of the study. A minimum of 9 participants were planned to receive cyclosporine as stable immunosuppressant therapy and a minimum of 9 participants were planned to receive tacrolimus as stable immunosuppressant therapy during Part 1. All participants will be receiving tacrolimus as stable immunosuppressant therapy during Part 2. In Part 1 of the study, participants with Metavir score of F1-F2, will receive a combination of study drugs - simeprevir, daclatasvir, and ribavirin for 24 weeks. In Part 2 of the study, participants with Metavir score F1-F4 will receive a dosing regimen of study drugs based on the data from Part 1 of the study. Safety evaluations will include assessments of adverse events, clinical laboratory tests, urinalysis, electrocardiogram, vital signs, and physical examination. The total study duration for each participant will be approximately 52 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | Participants with Metavir fibrosis score F1-F2 will receive treatment with combinational regimen of simeprevir, daclatasvir, and ribavirin along with cyclosporine or tacrolimus as stable immunosuppressant therapy. |
|
| Part 2 | Experimental | Participants with Metavir fibrosis score F1-F4 will receive treatment with combinational regimen of simeprevir, daclatasvir, and ribavirin along with tacrolimus as stable immunosuppressant therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simeprevir | Drug | Participants will receive 150 milligram capsule of simeprevir orally (by mouth) once daily with food for 24 weeks. In Part 1, if simeprevir pre-dose plasma concentration is greater than 7,300 nanogram per milliliter (ng/mL), participants will receive simeprevir 150 milligram capsule orally every other day to complete 24 weeks of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks After the End of Treatment (SVR 12) | Participants were considered to have achieved SVR12 if hepatitis C virus ribonucleic acid (HCV RNA) levels were less than (<) 25 international unit per milliliter (IU/mL) detectable or undetectable at 12 weeks after the end of treatment. | Week 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 4 Weeks After the End of Treatment (SVR 4) | Participants were considered to have achieved SVR4 if HCV RNA levels were (<) 25 IU/mL detectable or undetectable at 4 weeks after the end of treatment. | Week 28 |
| Percentage of Participants With Sustained Virologic Response 24 Weeks After the End of Treatment (SVR 24) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen R&D Ireland Clinical Trial | Janssen R&D Ireland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Essen | Germany | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28295849 | Derived | Forns X, Berenguer M, Herzer K, Sterneck M, Donato MF, Andreone P, Fagiuoli S, Cieciura T, Durlik M, Calleja JL, Marino Z, Shukla U, Verbinnen T, Lenz O, Ouwerkerk-Mahadevan S, Peeters M, Janssen K, Kalmeijer R, Jessner W. Efficacy, safety, and pharmacokinetics of simeprevir, daclatasvir, and ribavirin in patients with recurrent hepatitis C virus genotype 1b infection after orthotopic liver transplantation: The Phase II SATURN study. Transpl Infect Dis. 2017 Jun;19(3). doi: 10.1111/tid.12696. Epub 2017 May 4. |
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The study was conducted in 2 parts (part 1 and part 2) to sequentially enroll the participants. All analyses were conducted on the overall study population (part 1 and part 2 combined).
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| ID | Title | Description |
|---|---|---|
| FG000 | Cyclosporine | Participants received simeprevir (SMV) 150 milligram (mg) once daily (qd) or once every other day (qod) as applicable with food and daclatasvir (DCV) 60 mg qd with food and ribavirin (RBV) 1000 or 1200 milligram per day (mg/day) twice daily (bid) with food for 24 Weeks along with cyclosporine as immunosuppressant therapy for more than 3 months prior to the screening visit. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Daclatasvir | Drug | Participants will receive 60 milligram tablet of daclatasvir orally once daily for 24 weeks. |
|
| Ribavirin | Drug | Participants will receive 5 or 6 tablets of 200 milligram of ribavirin orally twice a day with food for 24 weeks. |
|
| Cyclosporine | Drug | Participants will receive cyclosporine as one of the stable immunosuppressant therapy (no change in dose in the last month) for more than 3 months prior to the screening visit. Cyclosporine will be administered as per the manufacturer's prescribing information for 24 weeks. |
|
| Tacrolimus | Drug | Participants will receive tacrolimus as one of the stable immunosuppressant therapy (no change in dose in the last month) for more than 3 months prior to the screening visit. Tacrolimus will be administered as per the manufacturer's prescribing information for 24 weeks. |
|
Participants were considered to have achieved SVR 24 if hepatitis C virus ribonucleic acid (HCV RNA) levels were (<) 25 IU/mL detectable or undetectable at 24 weeks after the end of treatment. |
| Week 48 |
| Percentage of Participants With HCV RNA (< 25 IU/mL Undetectable) and HCV RNA < 25 IU/mL Detectable | Percentage of participants with detectable and undetectable HCV RNA (<) 25 IU/mL during treatment at Weeks 2,4, 12, and 24 were reported. | Weeks 2, 4, 12, and 24 |
| Percentage of Participants With HCV RNA (<) 100 IU/mL at Week 4 | Percentage of participants with HCV RNA (<) 100 IU/mL at week 4 were reported. | Week 4 |
| Number of Participants With On-Treatment Failure | On-treatment failure is defined as participants who did not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of treatment. This was to include participants with: 1) Viral breakthrough, defined as a confirmed increase of greater than (>)1 log10 in HCV RNA from nadir, or confirmed HCV RNA of >100 IU/mL in participants whose HCV RNA had previously been \ | Up to Week 24 after actual EOT (week 24) |
| Number of Participants With Viral Breakthrough | Viral breakthrough is defined as a confirmed increase of >1 log10 IU/mL in HCV RNA level from the lowest level reached, or a confirmed HCV RNA level of >100 IU/mL in participants whose HCV RNA levels had previously been below the limit of quantification (<25 IU/mL detectable) or undetectable (<25 IU/mL undetectable) while on study treatment. | Up to week 24 |
| Number of Participants With Viral Relapse | Participants who did not achieve SVR12, with undetectable HCV RNA at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (>=) LLOQ during follow-up. | Up to Week 24 after actual EOT (week 24) |
| Hamburg |
| Germany |
| Warsaw | Poland |
| Barcelona | Spain |
| Madrid | Spain |
| Valencia | Spain |
| FG001 | Tacrolimus | Participants received SMV 150 mg qd or qod as applicable with food and DCV 60 mg qd with food and RBV 1000 or 1200 mg/day bid with food for 24 Weeks along with tacrolimus as immunosuppressant therapy for more than 3 months prior to the screening visit. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cyclosporine | Participants received simeprevir (SMV) 150 milligram (mg) once daily (qd) or once every other day (qod) as applicable with food and daclatasvir (DCV) 60 mg qd with food and ribavirin (RBV) 1000 or 1200 milligram per day (mg/day) twice daily (bid) with food for 24 Weeks along with cyclosporine as immunosuppressant therapy for more than 3 months prior to the screening visit. |
| BG001 | Tacrolimus | Participants received SMV 150 mg qd or qod as applicable with food and DCV 60 mg qd with food and RBV 1000 or 1200 mg/day bid with food for 24 Weeks along with tacrolimus as immunosuppressant therapy for more than 3 months prior to the screening visit. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 12 Weeks After the End of Treatment (SVR 12) | Participants were considered to have achieved SVR12 if hepatitis C virus ribonucleic acid (HCV RNA) levels were less than (<) 25 international unit per milliliter (IU/mL) detectable or undetectable at 12 weeks after the end of treatment. | Intent to treat (ITT) analysis set included all enrolled participants who took at least 1 dose of investigational medication. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 36 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sustained Virologic Response 4 Weeks After the End of Treatment (SVR 4) | Participants were considered to have achieved SVR4 if HCV RNA levels were (<) 25 IU/mL detectable or undetectable at 4 weeks after the end of treatment. | ITT analysis set included all enrolled participants who took at least 1 dose of investigational medication. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 28 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sustained Virologic Response 24 Weeks After the End of Treatment (SVR 24) | Participants were considered to have achieved SVR 24 if hepatitis C virus ribonucleic acid (HCV RNA) levels were (<) 25 IU/mL detectable or undetectable at 24 weeks after the end of treatment. | ITT analysis set included all enrolled participants who took at least 1 dose of investigational medication. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 48 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HCV RNA (< 25 IU/mL Undetectable) and HCV RNA < 25 IU/mL Detectable | Percentage of participants with detectable and undetectable HCV RNA (<) 25 IU/mL during treatment at Weeks 2,4, 12, and 24 were reported. | ITT analysis set included all enrolled participants who took at least 1 dose of investigational medication. | Posted | Number | percentage of participants | Weeks 2, 4, 12, and 24 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HCV RNA (<) 100 IU/mL at Week 4 | Percentage of participants with HCV RNA (<) 100 IU/mL at week 4 were reported. | ITT analysis set included all enrolled participants who took at least 1 dose of investigational medication. | Posted | Number | percentage of participants | Week 4 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With On-Treatment Failure | On-treatment failure is defined as participants who did not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of treatment. This was to include participants with: 1) Viral breakthrough, defined as a confirmed increase of greater than (>)1 log10 in HCV RNA from nadir, or confirmed HCV RNA of >100 IU/mL in participants whose HCV RNA had previously been \ | ITT analysis set included all enrolled participants who took at least 1 dose of investigational medication. | Posted | Number | participants | Up to Week 24 after actual EOT (week 24) |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Viral Breakthrough | Viral breakthrough is defined as a confirmed increase of >1 log10 IU/mL in HCV RNA level from the lowest level reached, or a confirmed HCV RNA level of >100 IU/mL in participants whose HCV RNA levels had previously been below the limit of quantification (<25 IU/mL detectable) or undetectable (<25 IU/mL undetectable) while on study treatment. | ITT analysis set included all enrolled participants who took at least 1 dose of investigational medication. | Posted | Number | participants | Up to week 24 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Viral Relapse | Participants who did not achieve SVR12, with undetectable HCV RNA at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (>=) LLOQ during follow-up. | Intent to treat (ITT) analysis set included all enrolled participants who took at least 1 dose of investigational medication. | Posted | Number | participants | Up to Week 24 after actual EOT (week 24) |
|
|
Up to 52 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cyclosporine | Participants received simeprevir (SMV) 150 milligram (mg) once daily (qd) or once every other day (qod) as applicable with food and daclatasvir (DCV) 60 mg qd with food and ribavirin (RBV) 1000 or 1200 milligram per day (mg/day) twice daily (bid) with food for 24 Weeks along with cyclosporine as immunosuppressant therapy for more than 3 months prior to the screening visit. | 4 | 10 | 10 | 10 | ||
| EG001 | Tacrolimus | Participants received SMV 150 mg qd or qod as applicable with food and DCV 60 mg qd with food and RBV 1000 or 1200 mg/day bid with food for 24 Weeks along with tacrolimus as immunosuppressant therapy for more than 3 months prior to the screening visit. | 4 | 25 | 23 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Escherichia Urinary Tract Infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Genital Herpes | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Facial Bones Fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hepatic Encephalopathy | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Loss of Consciousness | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Micturition Disorder | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Haemolytic Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Ocular Icterus | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Visual Acuity Reduced | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Aphthous Stomatitis | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Lip Dry | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Tongue Dry | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Gait Disturbance | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Mucous Membrane Disorder | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Restless Legs Syndrome | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Anger | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hallucination, Visual | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Vulvovaginal Pain | Reproductive system and breast disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Photosensitivity Reaction | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
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A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Leader | Janssen Research & Development | ClinicalTrialDisclosure@its.jnj.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| 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 |
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Not provided
| ID | Term |
|---|---|
| D000069616 | Simeprevir |
| C549273 | daclatasvir |
| D012254 | Ribavirin |
| D016572 | Cyclosporine |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D018942 | Macrolides |
| D007783 | Lactones |
Not provided
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| Male |
|
| Spain |
|
| Poland |
|
| Italy |
|
| Participants |
|
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| Participants |
|
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| Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| Participants |
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