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An open label extension to the RHB-104-01 Study.
An Open Label Phase III Study to Assess the Efficacy and Safety of Fixed-Dose Combination RHB-104 in Subjects with Active Crohn's Disease Despite 26 Weeks of Participation in the MAP US RHB-104-01 Study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RHB-104 - patients on ACTIVE therapy in RHB-104-01 study | Experimental | Subjects who were on the active therapy arm in the RHB-104-01 clinical study will continue to receive RHB-104 at 5 capsules twice a day in addition to the standard of care they received in the RHB-104-01 clinical study |
|
| RHB-104 - patients on PLACEBO therapy in RHB-104-01 study | Experimental | Subjects who were on the active therapy arm in the RHB-104-01 clinical study will receive RHB-104 at 5 capsules twice a day in addition to the standard of care they received in the RHB-104-01 clinical study. The RHB-104 will be ramped up beginning at 1 capsule twice per day in week 1 increasing to 2 capsules twice per day in week 2, 3 capsules twice per day in week 3, 4 capsules per day in week 4 and achieving 5 capsules per day for the remainder of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine) | Drug | For patients on ACTIVE or PLACEBO in the parent study (RHB-104-01), who were not in remission after 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients in Remission at Week 16 | The number of patients who achieved a reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150 points. Lower CDAI scores indicate a better outcome. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Response at Week 16 | Reduction of the total Crohn's Disease Activity Index (CDAI) score by a minimum of 100 points Lower CDAI scores indicate a better outcome. | Week 16 |
| The Number of Weeks for Patients to Achieve Remission |
| Measure | Description | Time Frame |
|---|---|---|
| Increase in Milliseconds (ms) QT Wave | The increase in the number of milliseconds change-from-baseline to week 52 in QTcF (Fridericia's Correction Formula of QT wave interval) (based on cardiac safety report). | week 52 |
Inclusion Criteria:
OR
More than 26 weeks, with a CDAI ≥150 at Visit Week 26 and all subsequent visits, and subject is between Week 26 and 52 within 4 weeks (28 days) of site activation (e.g. Subject with CDAI = 249 at week 26 and who is at week 38 at the time of site's activation for RHB-104-04 has a 4-week window to be enrolled in the open label study via the Optional Screening Visit)
Current treatment with at least one of the following therapies which may be discontinued by the investigator as clinically indicated after 8 weeks of open label RHB-104 treatment:
White blood cell count ≥ 3.5x109 at screening (RHB-104-01 Visit Week 26 visit or Optional Screening visit)
Subject agrees to use the following effective contraceptive methods
In regions where local regulatory contraceptive requirements differ, the ICF (Informed Consent Form) will reflect local policies.
Exclusion Criteria:
Positive stool results for C. difficile.
Currently diagnosed or history of uveitis confirmed by either an ophthalmologist or optometrist.
Treatment with any medication that causes QT prolongation or Torsades de Pointes, including but not limited to: amiodarone, amitriptyline, astemizole, cisapride, citalopram dose greater than 20 mg/day, dihydroergotamine, disopyramide, dofetilide, dronedarone, ergotamine, ibutilide, ondansetron or other 5-HT3 (5-hydroxytryptamine three) receptor antagonists, pimozide, procainamide, quinidine, quinine, quinolones, ranolazine, risperidone, sotalol, terfenadine and tolterodine. QT prolonging drugs may be referenced at the CredibleMeds® web site: https://crediblemeds.org/index.php/drugsearch/
Treatment with the following CYP3A4 interactive medications: alfentanyl, alprazolam, amlodipine, anti-retroviral agents, apixaban, aprepitant, aripiprazole, atorvastatin, boceprevir, buspirone, carbamazepine, carvedilol, colchicine, cyclosporine, digoxin, diltiazem, estrogens, felodipine, fluconazole, fluvoxamine, grapefruit juice, haloperidol, ketoconazole, lovastatin, lurasidone, metoprolol, nefazodone, nifedipine, nisoldipine, nitrendipine, propranol, roflumilast, simvastatin, St. John's wort, and voriconazole.
Any evidence of any newly diagnosed significant hematological, hepatic, renal, cardiac, pulmonary, metabolic, neurological, psychiatric or other disease (e.g. porphyria) that might interfere with subject's ability to safely enter and or complete the study requirements.
Females who have a positive pregnancy test or are lactating.
Refusal to sign the study informed consent form.
Inability to be able to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study.
Clinically significant abnormalities of hematology or biochemistry as confirmed by repeat testing based on investigator's discretion, including but not limited to, elevations greater than 2 times the upper limit of normal of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) or creatinine clearance less than 60 ml/min at screening via estimated Cockcroft-Gault formula:
Creatinine Clearance = [140 - age in years] * weight (kg) / 72 * Serum Creatinine (mg/dl) [multiply estimated rate by 0.85 for women], using actual body weight.
QTcF (shortening of the QT interval in the heart rate) >450ms in males and QTcF>460ms in females, bundle branch block, or major ST or T wave abnormalities that make the assessment of the QT impossible.
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| Name | Affiliation | Role |
|---|---|---|
| Ira N Kalfus, MD | RedHill Biopharma Limited | Study Director |
| David Y Graham, MD | Department of Medicine / Gastroenterology, Baylor College of Medicine, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Digestive Care Associates, Inc., 1000 Laurel Street | San Carlos | California | 94070 | United States | ||
| Gastrointestinal Specialists of Georgia PC 711 Canton Rd. #300 |
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| Label | URL |
|---|---|
| RedHill home page | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | RHB-104 From RHB-104 | RHB-104 (fixed-dose combination 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine): For patients who were in the RHB-104 arm but are not in remission after 26 weeks in the RHB-104-01 study. |
| FG001 | RHB-104 From Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 23, 2019 | Sep 20, 2020 |
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Active
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|
[Date of first observed remission (CDAI less than 150) - date of first dose, or date of randomization if not dosed, plus 1] / 7 days. Subject who never experience remission during the study are censored at the time of their last CDAI assessment.
| Baseline through week 52 |
| Number of Weeks the Patients Are in Remission | Duration of remission is defined as the number of weeks the subject is in remission (CDAI score < 150). It is calculated as the first date following remission at which CDAI is ≥150 minus the date of first remission, plus 1 day, divided by 7. Subjects who experienced remission and continued to be in remission at the time of their last CDAI assessment are censored at the date of their last CDAI assessment. | Baseline through week 52 |
| Number of Weeks to Achieve Response | [Date of first observed response (a reduction from baseline of ≥ 100 in CDAI score) - Date of first dose or date of randomization if not dosed + 1] / 7 Days. Subjects who never experienced response during the study are censored at the date of their last CDAI assessment. | Baseline through week 52 |
| Number of Weeks the Patients Are in Response. | Duration of response is defined as the number of weeks the subject is in a state of response (a reduction from baseline of ≥ 100 in CDAI score). It is calculated as the first date following response at which the reduction from baseline in CDAI is <100 minus the date of first response, plus 1 day, divided by 7. Subjects who experienced response and continued to be in response at the time of their last CDAI assessment are censored at the date of their last CDAI assessment. | Baseline through week 52 |
| Durable Remission Week 16 Through Week 52 | When a subject is in remission with a maximum CDAI score of 149 at every visit from week 16 through and including week 52. | Week 16 through week 52 |
| Marietta |
| Georgia |
| 30060 |
| United States |
| Cotton-O'Neil Clinical Research Center, 720 SW Lane St. | Topeka | Kansas | 66606 | United States |
| Chevy Chase Clinical Research, 5550 Friendship Blvd. | Chevy Chase | Maryland | 20815 | United States |
| Commonwealth Clinical Studies, 189 Quincy St. | Brockton | Massachusetts | 02302-2926 | United States |
| ClinSearch 6035 Shallowford Road Suite 109 | Chattanooga | Tennessee | 37421 | United States |
| Discovery Clinical Services Ltd., 601 A Discovery St. | Victoria | British Columbia | V8T 5G4 | Canada |
| Gastroenterologie s.r.o. Manesova 646 | Hradec Králové | 500 02 | Czechia |
| Hepato-Gastroenterologie HK, s.r.o., Hradecka poliklinika III Trida Edvarda Benese 1549/34 | Hradec Králové | 500 12 | Czechia |
| Ha'Emek Medical Center, Institute of Gastroenterology and Liver diseases, 21 Yitshak Rabin Boulevard | Afula | 1834111 | Israel |
| Gastroenterology Institute, Division of Medicine, Hadassah - Hebrew University Medical Center POB 12000 | Jerusalem | 91120 | Israel |
| Meir Medial Center, 59 Tchemacovsky St. | Kfar Saba | 44281 | Israel |
| Christchurch Hospital, 2 Riccarton Rd. | Christchurch | Canterbury | 80011 | New Zealand |
| Waikato Hospital, Department of Gastroenterology, Level B1, Menzies Building, Pembroke Street | Hamilton | Waikato Region | 3240 | New Zealand |
| NZOZ Specjalistyczne Centrum Gastrologii GASTROMED, Wiejska 81 | Bialystok | 15-351 | Poland |
| Samodzielny Publiczny Zakład Opieki Zdrowotnej MSW W Gdańsku Oddział Gastroenterologiczny, Ul. Kartuska 4/6 | Gdansk | 80-104 | Poland |
| UNICARDIA Specjalistyczne Centrum Leczenia Chorob Serca i Naczyn & UNIMEDICA. Specjalistyczne Centrum Medyczne Sp. z o.o., Kluczborska 15 | Krakow | 31-271 | Poland |
| Wojewodzki Szpital Kliniczny w Olsztynie Oddzial Gastroenterologiczny, Zolnierska 18 | Olsztyn | 10-561 | Poland |
| EuroMedis sp. z.o.o., Al. Powstancow Wielkopolskich 33a | Szczecin | 70-111 | Poland |
| Centralny Szpital Kliniczny MSW w Warszawie. Klinika Chorob Wewnetrznych i Gastroenterologii, Woloska 137, | Warsaw | 02-507 | Poland |
| ARS MEDICA s.c., Powstancow Slaskich 56A/2 | Wroclaw | 53-333 | Poland |
| Clinical Department of Gastroenterology and Hepatology Clinic for Internal Diseases Clinical Hospital Center Zvezdara Dimitrija Tucovica 161 | Belgrade | 11000 | Serbia |
| Department of Gastroenterology and Hepatology, Clinical Hospital Center Zemun, Vukova 9 | Belgrade | 11080 | Serbia |
| Center for Gastroenterohepatology, Clinic for Internal Medicine, Clinical Center Kragujevac, Zmaj Jovina 30 | Kragujevac | 34000 | Serbia |
RHB-104 (fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine): For patients who were in the placebo arm but are not in remission after 26 weeks in the RHB-104-01 study. |
| COMPLETED |
|
| NOT COMPLETED |
|
Total Study
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| ID | Title | Description |
|---|---|---|
| BG000 | RHB-104 | RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age measured in years at Baseline | 16 subjects who transferred to the RHB-104-04 study were on RHB-104 in the RHB-104-01 (parent) study while 38 subjects were on placebo. | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | 16 subjects who transferred to the RHB-104-04 study were on RHB-104 in the RHB-104-01 (parent) study while 38 subjects were on placebo. | Count of Participants | Participants |
| |||||||||||||||||
| Race (NIH/OMB) | 16 subjects who transferred to the RHB-104-04 study were on RHB-104 in the RHB-104-01 (parent) study while 38 subjects were on placebo. | Count of Participants | Participants |
| |||||||||||||||||
| Baseline Crohn's Disease Activity Index (CDAI) score | Generally, CDAI score can range from 0-approx. 600. (in this protocol up to 450) CDAI scores of 150-219 describe mildly active disease, while scores of 220-450 describe moderately active disease and score above 450 describe severe disease. | 16 subjects who transferred to the RHB-104-04 study were on RHB-104 in the RHB-104-01 (parent) study while 38 subjects were on placebo. | Mean | Standard Deviation | units on a scale |
|
| 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 | Number of Patients in Remission at Week 16 | The number of patients who achieved a reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150 points. Lower CDAI scores indicate a better outcome. | Posted | Count of Participants | Participants | Week 16 |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Response at Week 16 | Reduction of the total Crohn's Disease Activity Index (CDAI) score by a minimum of 100 points Lower CDAI scores indicate a better outcome. | Number of subjects achieved response | Posted | Count of Participants | Participants | Week 16 |
|
| ||||||||||||||||||||||||||||||
| Secondary | The Number of Weeks for Patients to Achieve Remission | [Date of first observed remission (CDAI less than 150) - date of first dose, or date of randomization if not dosed, plus 1] / 7 days. Subject who never experience remission during the study are censored at the time of their last CDAI assessment. | Number of subjects achieved remission, n (%) RHB-104 from RHB-104: 6 (37.5); RHB-104 from Placebo: 20 (52.6). Number of patients censored due to never achieving remission, n (%) RHB-104 from RHB-104: 10 (62.5); RHB-104 from Placebo: 18 (47.4) | Posted | Median | 95% Confidence Interval | weeks | Baseline through week 52 |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Weeks the Patients Are in Remission | Duration of remission is defined as the number of weeks the subject is in remission (CDAI score < 150). It is calculated as the first date following remission at which CDAI is ≥150 minus the date of first remission, plus 1 day, divided by 7. Subjects who experienced remission and continued to be in remission at the time of their last CDAI assessment are censored at the date of their last CDAI assessment. | Reached duration of remission (dropped out of remission during the study), n (%): RHB-104 from RHB-104 5 (83.3); RHB-104 from Placebo: 8 (40.0). Number of patients censored due to remaining in remission during the study, n (%): RHB-104 from RHB-104 1 (16.7); RHB-104 from Placebo: 12 (60.0) | Posted | Median | 95% Confidence Interval | weeks | Baseline through week 52 |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Weeks to Achieve Response | [Date of first observed response (a reduction from baseline of ≥ 100 in CDAI score) - Date of first dose or date of randomization if not dosed + 1] / 7 Days. Subjects who never experienced response during the study are censored at the date of their last CDAI assessment. | Number of subjects achieved response, n (%): RHB-104 from RHB-104 5 (31.3); RHB-104 from Placebo 21 (55.3). Number of patients censored due to never achieving response, n (%): RHB-104 from RHB-104 11 (68.8); RHB-104 from Placebo 17 (44.7) | Posted | Median | 95% Confidence Interval | Weeks | Baseline through week 52 |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Weeks the Patients Are in Response. | Duration of response is defined as the number of weeks the subject is in a state of response (a reduction from baseline of ≥ 100 in CDAI score). It is calculated as the first date following response at which the reduction from baseline in CDAI is <100 minus the date of first response, plus 1 day, divided by 7. Subjects who experienced response and continued to be in response at the time of their last CDAI assessment are censored at the date of their last CDAI assessment. | Reached duration of response (dropped out of response during the study), n (%): RHB-104 from RHB-104 3 (60.0); RHB-104 from placebo 7 (33.3). Number of patients censored due to remaining in response during the study, n (%): RHB-104 from RHB-104 2 (40.0); RHB-104 from placebo 14 (66.7) | Posted | Median | 95% Confidence Interval | Weeks | Baseline through week 52 |
| ||||||||||||||||||||||||||||||
| Secondary | Durable Remission Week 16 Through Week 52 | When a subject is in remission with a maximum CDAI score of 149 at every visit from week 16 through and including week 52. | Posted | Count of Participants | Participants | Week 16 through week 52 |
|
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Increase in Milliseconds (ms) QT Wave | The increase in the number of milliseconds change-from-baseline to week 52 in QTcF (Fridericia's Correction Formula of QT wave interval) (based on cardiac safety report). | Posted | Least Squares Mean | 90% Confidence Interval | ms | week 52 |
|
|
Baseline through 30 days after last dose of study drug, or up to 13 months.
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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 | RHB-104 From RHB-104 | RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine: For patients who were in the RHB-104 arm but are not in remission after 26 weeks in the RHB-104-01 study. | 0 | 16 | 1 | 16 | 14 | 16 |
| EG001 | RHB-104 From Placebo | RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, 10 mg clofazimine: For patients who were in the placebo arm but are not in remission after 26 weeks in the RHB-104-01 study. | 0 | 38 | 4 | 38 | 24 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Peripheral Arterial Occlusive Disease | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crohn's Disease | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Gingival discolouration | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Lip dry | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Siliva discolouration | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Blood creatine phosphokinase abnormal | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Transaminases | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Inflective scleritis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pirexia | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Porokeratosis | Congenital, familial and genetic disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Reza Fathi, Sn. VP Research and Development | Redhill Biopharma | 972-(0)3-541-3131 | reza@redhillbio.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Dec 16, 2016 | Sep 20, 2020 | Prot_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017291 | Clarithromycin |
| D017828 | Rifabutin |
| D002991 | Clofazimine |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010619 | Phenazines |
| D006575 | Heterocyclic Compounds, 3-Ring |
Not provided
Not provided
|
| Male |
|
| RHB-104 from placebo |
|
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| RHB-104 from placebo |
|
|
| RHB-104 from placebo |
|
|
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| Participants |
|
|
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
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