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NCT ID: NCT04629248 Active, not recruiting - Clinical trials for Primary Membranous Nephropathy

A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy

MAJESTY
Start date: June 25, 2021
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics (PK) of obinutuzumab compared with tacrolimus in participants with primary membranous nephropathy (pMN).

NCT ID: NCT04627285 Active, not recruiting - Epilepsy Clinical Trials

A Study to Test the Long-term Use of Oral Lacosamide in Pediatric Study Participants Who Completed NCT01964560 (EP0034) or NCT00938912 (SP848) and Received Lacosamide Treatment

Start date: December 28, 2020
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the long-term use of lacosamide oral solution dosed at 2 mg/kg/day to 12 mg/kg/day when administered to pediatric study participants with epilepsy who have completed NCT01964560 (EP0034) or NCT00938912 (SP848).

NCT ID: NCT04624243 Active, not recruiting - Schizophrenia Clinical Trials

Efficacy and Safety of MK-8189 in Participants With an Acute Episode of Schizophrenia (MK-8189-008)

Start date: December 15, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of MK-8189 at a range of doses (8 mg, 16 mg, and 24 mg once daily) in adult participants who have an acute episode of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) criteria. The primary hypotheses are the following: (1) MK-8189 24 mg is superior to placebo in reducing the Week 6 mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score (2) MK-8189 16 mg is superior to placebo in reducing the Week 6 mean change from baseline in PANSS total score. With Amendment 4, enrollment was changed to approximately 500 participants with removal of the MK-8189 8 mg treatment arm. Participants enrolled before Amendment 4 that have been assigned to 8 mg MK-8189 will remain on 8 mg MK-8189 per protocol.

NCT ID: NCT04624204 Recruiting - Clinical trials for Small Cell Lung Cancer

Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)

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

The purpose of this study is to compare overall survival (OS) and progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR). Hypothesis (H1): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR. Hypothesis (H2): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR. Hypothesis (H3): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to OS. Hypothesis (H4): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to OS.

NCT ID: NCT04620733 Completed - Clinical trials for Primary Biliary Cholangitis

RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Start date: April 21, 2021
Phase: Phase 3
Study type: Interventional

To evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of treatment compared to placebo

NCT ID: NCT04615273 Completed - Clinical trials for Growth Hormone Deficiency

A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency

foresiGHt
Start date: December 3, 2020
Phase: Phase 3
Study type: Interventional

A 38 week dosing trial of lonapegsomatropin, a long-acting growth hormone product, administered once-a-week versus placebo-control. A daily somatropin product arm is also included to assist clinical judgement on the trial results. Approximately 240 adults (males and females) with growth hormone deficiency will be included. Randomization will occur in a 1:1:1 ratio (lonapegsomatropin : placebo : daily somatropin product). This is a global trial that will be conducted in, but not limited to, the United States, Europe, and Asia.

NCT ID: NCT04614337 Active, not recruiting - Clinical trials for Growth Hormone Deficiency

Phase 2 Study of LUM-201 in Children With Growth Hormone Deficiency (OraGrowtH210 Trial)

OraGrowtH210
Start date: December 31, 2020
Phase: Phase 2
Study type: Interventional

This is a multi-national trial. The goals of the trial are to study LUM-201 as a possible treatment for Pediatric Growth Hormone Deficiency (PGHD) and investigate a predictive enrichment marker (PEM) strategy to select subjects likely to respond to therapy with LUM-201.

NCT ID: NCT04607837 Active, not recruiting - Ulcerative Colitis Clinical Trials

Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis

GLADIATOR UC
Start date: April 12, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately active ulcerative colitis in adult participants.

NCT ID: NCT04607798 Completed - Menopause Clinical Trials

Multi-polar RF and PEMF for Treatment of Vulvovaginal Atrophy

Start date: October 3, 2017
Phase: N/A
Study type: Interventional

The study evaluates the use of multi-polar radiofrequency (RF) and pulsed electro-magnetic fields (PEMF) energies for the treatment of symptoms related to genitourinary syndrome of menopause (GSM)/vulvovaginal atrophy (VVA). All subjects will receive a total of three internal treatments at four week intervals. Subjects will be followed up at one and four months after treatment is complete.

NCT ID: NCT04607668 Terminated - Clinical trials for Colorectal Cancer Metastatic

Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer (mCRC):

PRESERVE1
Start date: October 16, 2020
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, global, multicenter, Phase 3 trial evaluating the impact of trilaciclib on myelopreservation and anti-tumor efficacy when administered prior to FOLFOXIRI/bevacizumab in patients with pMMR/MSS mCRC who have not received systemic therapy for metastatic disease.