STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-90001 IN SUBJECTS WITH NONALCOHOLIC STEATOHEPATITIS (NASH) AND STAGE 3 OR STAGE 4 LIVER FIBROSIS : A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, DOSEFINDING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-90001 IN SUBJECTS WITH NONALCOHOLIC STEATOHEPATITIS (NASH) AND STAGE 3 OR STAGE 4 LIVER FIBROSIS
| Medienart: |
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Klinische Studie| Erscheinungsjahr: |
2020 |
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| Erschienen: |
2020 |
| Enthalten in: |
WHO International Clinical Trials Registry Platform - (2020) vom: 01. Feb. Zur Gesamtaufnahme - year:2020 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Anmerkungen: |
WHO International Clinical Trials Registry Platform (https://www.who.int/ictrp/en/), First posted: 09-08-2019, Last updated: 2022-11-24 |
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| ICTRP ID: |
EUCTR2018-004431-79-ES |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
CTG00662314X |
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| 245 | 1 | 0 | |a STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-90001 IN SUBJECTS WITH NONALCOHOLIC STEATOHEPATITIS (NASH) AND STAGE 3 OR STAGE 4 LIVER FIBROSIS |b A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, DOSEFINDING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-90001 IN SUBJECTS WITH NONALCOHOLIC STEATOHEPATITIS (NASH) AND STAGE 3 OR STAGE 4 LIVER FIBROSIS |
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| 500 | |a WHO International Clinical Trials Registry Platform (https://www.who.int/ictrp/en/), First posted: 09-08-2019, Last updated: 2022-11-24 | ||
| 650 | 4 | |a Medical Condition: Confirmed diagnosis of NASH and Stage 3 or Stage 4 fibrosis based upon the NASH Clinical Research Network (CRN) Histologic Scoring System and a nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) of 4 or higher, with a score of at least 1 for each of the three components (steatosis, hepatocellular ballooning, and lobular inflammation). MedDRA version: 22.0 Level: PT Classification code 10053219 Term: Non-alcoholic steatohepatitis System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Phase: Phase 2 | |
| 650 | 4 | |a Recruitment Status: Authorised-recruitment may be ongoing or finished | |
| 650 | 4 | |a 610 | |
| 773 | 0 | 8 | |i Enthalten in |t WHO International Clinical Trials Registry Platform |g (2020) vom: 01. Feb. |
| 773 | 1 | 8 | |g year:2020 |g day:01 |g month:02 |
| 856 | 4 | 0 | |u https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-004431-79 |z kostenfrei |3 Volltext |
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