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NCT ID: NCT04675970 Active, not recruiting - Clinical trials for Premature Ovarian Failure

Long Term Follow up Patients With Premature Ovarian Failure ex Vivo Gene Therapy

UB-OVF
Start date: September 1, 2020
Phase:
Study type: Observational

This is a multi-centers of long term safety and efficacy follow up study for patients with premature ovarian failure (the women aged younger than 40 years, who present with amenorrhoea, hypergonadotropic hypogonadism, and infertility) who have been treated with ex vivo gene therapy drug product in Institute of Bio-Stem Cell Rehabilitation UAB - sponsored clinical studies. After completing the parent clinical study (approximately 6 month), eligible subject will be followed for additional 2 years for total of 2 years and 6 month post drug product infusion. No investigation drug product will be administered in the study

NCT ID: NCT04657991 Active, not recruiting - Melanoma Clinical Trials

A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma

Start date: January 15, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to learn about the effects of three study medicines (encorafenib, binimetinib, and pembrolizumab) given together for the treatment of melanoma that: - is advanced or metastatic (spread to other parts of the body); - has a certain type of abnormal gene called "BRAF"; and - has not received prior treatment. All participants in this study will receive pembrolizumab at the study clinic once every 3 weeks as an intravenous (IV) infusion (given directly into a vein). In addition, half of the participants will take encorafenib and binimetinib orally (by mouth) at home every day. Participants may receive pembrolizumab for up to two years. Those participants taking encorafenib and binimetinib can continue until their melanoma is no longer responding. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.

NCT ID: NCT04657224 Active, not recruiting - Clinical trials for Chronic Lymphocytic Leukemia

A Study of JNJ-64264681 and JNJ-67856633 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

Start date: February 25, 2021
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to determine: the recommended Phase 2 doses (RP2Ds) of JNJ-64264681 and JNJ 67856633 when administered together in participants with B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) (Part A - Dose Escalation); and the safety of the RP2Ds for this combination in different histologies/participant populations (Part B - Cohort Expansion).

NCT ID: NCT04642911 Active, not recruiting - Diabete Type 2 Clinical Trials

Longterm Follow-up of Subjects With Diabetes 2 Type Treatment With ex Vivo Gene Therapy

AUB001
Start date: October 15, 2020
Phase:
Study type: Observational

This is a multicenter, long term safety and efficacy follow up study for with insulin dependent diabetes 2 type who have been treated with ex vivo gene therapy product in Ukraine Association of Biobank bio-sponsored clinical studies. After completing the parent clinical study (2 years),eligible subjects will be followed for an additional 8 years for total 10 years post-drugproduct infusion. No investigation drug product will be administered in the study

NCT ID: NCT04634877 Active, not recruiting - Clinical trials for Endometrial Neoplasms

Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053)

Start date: January 10, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS.

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: 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.