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NCT ID: NCT04277546 Terminated - Ulcerative Colitis Clinical Trials

Open-label Extension Study of Brazikumab in Ulcerative Colitis

Expedition
Start date: March 3, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this OLE Study D5272C00002 (Legacy #3151-202-008) is to permit participants who previously enrolled in the double-blind Study D5272C00001 (Legacy #3151-201-008) to receive brazikumab, allowing for long-term observation of safety and efficacy in these participants treated with brazikumab. There are no formal hypotheses to be tested. Safety and efficacy data obtained in this study will be included in regulatory product submissions as appropriate.

NCT ID: NCT04210843 Terminated - Clinical trials for Chronic Spontaneous Urticaria

Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab

Start date: April 8, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this extension study was to establish efficacy and safety of ligelizumab. This was assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who had completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment. This study also fulfilled the Novartis commitment to provide post-trial access to patients who had completed studies: CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356), CQGE031C2202 (NCT03437278) or CQGE031C1301 (NCT03907878).

NCT ID: NCT04152863 Terminated - Clinical trials for Advanced/Metastatic Melanoma

Efficacy, Safety, and Tolerability of Gebasaxturev (V937) Administered Intravenously or Intratumorally With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone in Participants With Advanced/Metastatic Melanoma (V937-011)

Start date: June 5, 2020
Phase: Phase 2
Study type: Interventional

This is a Phase 2 study to assess the efficacy, safety, and tolerability of gebasaxturev administered both intratumorally (ITu) and intravenously (IV) as combination therapy with pembrolizumab (MK-3475) versus pembrolizumab alone in anti-programmed cell death ligand 1 (anti-PD-L1)-treatment-naive participants with advanced/metastatic melanoma. The primary hypothesis of the study is that gebasaxturev administered either ITu or IV in combination with pembrolizumab results in a superior objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR), compared to pembrolizumab alone. This study will be terminated once all participants finish treatment with V937. Participants eligible to continue to receive pembrolizumab will be transferred to MK-3475-587 study.

NCT ID: NCT04065841 Terminated - Clinical trials for Non Alcoholic Steatohepatitis (NASH)

Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.

ELIVATE
Start date: December 30, 2019
Phase: Phase 2
Study type: Interventional

Randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and tolerability of oral tropifexor & licogliflozin combination therapy and each monotherapy, compared with placebo for treatment of adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.

NCT ID: NCT04000009 Terminated - Clinical trials for Adjunctive Treatment of Major Depressive Disorder

Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment

Start date: June 6, 2019
Phase: Phase 3
Study type: Interventional

To assess the safety and tolerability of long-term pimavanserin treatment in subjects with major depressive disorder and inadequate response to antidepressant treatment.

NCT ID: NCT03961815 Terminated - Crohn's Disease Clinical Trials

Open-label Extension Study of Brazikumab in Crohn's Disease

INTREPID OLE
Start date: January 6, 2020
Phase: Phase 3
Study type: Interventional

The purpose of Study D5271C00002 (Legacy #3150-303-008) is to permit participants in D5271C00001 (Legacy #3150-301-008) to receive open-label brazikumab in Study D5271C00002 (Legacy #3150-303-008). This will permit long-term observation of safety in these participants with brazikumab.

NCT ID: NCT03920254 Terminated - Clinical trials for Ulcerative Colitis (UC)

TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study

Start date: July 23, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

A 3-Year Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis who have participated in the Maintenance Study of Protocol 0157

NCT ID: NCT03893565 Terminated - Colitis, Ulcerative Clinical Trials

Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative Colitis

Start date: May 6, 2019
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multicenter, randomized, double-blind, parallel group, placebo-controlled study to investigate the safety, tolerability, efficacy and dose-response of GSK2831781 in participants with moderate to severe active ulcerative colitis. The study consists of a 5-week screening window, 10-week Induction Phase, 30-week double-blind Extended Treatment Phase (ETP) with 42-week Follow-Up Phase. Non-Responders identified following the Week 10 assessment will be allocated to open label treatment, consisting of Induction (Weeks 12 to 22), an Open label ETP (Weeks 22 to 42) and a follow-Up to Week 54.

NCT ID: NCT03892161 Terminated - HIV Infections Clinical Trials

Clinical Evaluation of Adjusted Doses of Darunavir/Ritonavir With Rifampicin in HIV-infected Volunteers

Darifi
Start date: April 12, 2018
Phase: Phase 1
Study type: Interventional

The DaRifi study aims: 1. Develop adjusted doses of darunavir/ritonavir for use in HIV-infected patients requiring co-treatment of TB with a rifampicin-based regimen. 2. Compare the steady state pharmacokinetics of doubled doses of DRV/r with rifampicin (in once daily and 12-hourly approaches) to standard daily doses without rifampicin. 3. Twenty-eight volunteers will be enrolled for a target of 24 participants completing the study.

NCT ID: NCT03849898 Terminated - Clinical trials for Mandibular Fractures

Patients 60 Years and Older Suffering From Mandibular Fractures Registry

Start date: October 14, 2019
Phase:
Study type: Observational [Patient Registry]

Approximately 200 of patients of 60 years or older who present a mandibular fracture will be enrolled in this registry. All patients will be treated and followed up according to the local standard (routine) of care at around 2 weeks, 6 weeks, 3 months and 6 months after treatment.