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NCT ID: NCT04853368 Terminated - Clinical trials for Cystic Fibrosis (CF)

Study to Evaluate Adverse Events and Change in Disease Activity With Oral Capsules of Galicaftor/Navocaftor/ABBV-119 or Galicaftor/Navocaftor/ABBV-576 Combination Therapies in Adult Participants With Cystic Fibrosis

Start date: September 20, 2021
Phase: Phase 2
Study type: Interventional

Cystic Fibrosis (CF) is a rare, life-threatening, genetic disease that affects the lungs and digestive system, significantly impairing the quality of life, with those affected having a median age of death at 40. The main objective of this study is to assess how safe and effective is the combination therapy of galicaftor/navocaftor/ABBV-119 or Galicaftor/Navocaftor/ABBV-576 in adult participants with CF who are homozygous or heterozygous for the F508del mutation in each arm. Galicaftor/Navocaftor/ABBV-119 combination therapy and Galicaftor/Navocaftor/ABBV-576 is being developed as an investigational drug for the treatment of CF. Study doctors place participants in 1 of the 4 groups, called treatment arms. Each group receives a different treatment. Around 90 adult participants with a diagnosis of CF will be enrolled in the study around approximately 35 sites worldwide. Participants in arm 1 will receive oral capsules of galicaftor/navocaftor dual combination for 28 days followed by galicaftor/navocaftor/ABBV-119 triple combination for 28 days. Participants in arms 2 and 3 will receive the galicaftor/navocaftor/ABBV-119 triple combination or placebo for 28 days. Participants in arm 4 will receive galicaftor/navocaftor/ABBV-576 triple combination therapy for 28 days. For all study arms, ABBV-576, galicaftor, navocaftor, will be given once daily and ABBV-119 twice a day. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT04845321 Terminated - Healthy Volunteers Clinical Trials

VNRX-9945 Safety and Pharmacokinetics in Healthy Adult Volunteers

Start date: June 23, 2021
Phase: Phase 1
Study type: Interventional

This is a 2-part first-in-human dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-9945.

NCT ID: NCT04820686 Terminated - Chronic Hepatitis B Clinical Trials

A Study Evaluating Treatment Regimens Containing Vebicorvir (ABI-H0731) in Participants With Chronic Hepatitis B Infection

Start date: May 7, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if vebicorvir (VBR, ABI-H0731) in combination with AB-729 is safe and effective in participants with chronic hepatitis B infection (cHBV) receiving a standard of care nucleos(t)ide/reverse transcriptase inhibitor (SOC NrtI).

NCT ID: NCT04786964 Terminated - Clinical trials for Metastatic Non-squamous Non Small Cell Lung Cancer

Study of Pemetrexed+Platinum Chemotherapy With or Without Cosibelimab (CK-301) in First Line Metastatic Non-squamous Non-Small Cell Lung Cancer

CONTERNO
Start date: December 8, 2021
Phase: Phase 3
Study type: Interventional

This is an efficacy and safety study of cosibelimab (CK-301) combined with pemetrexed/platinum chemotherapy versus pemetrexed/platinum chemotherapy alone in participants with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease. Participants will be randomly assigned in a 2:1 ratio to receive cosibelimab combined with pemetrexed/platinum (Investigators choice of cisplatin or carboplatin), OR pemetrexed/platinum (Investigators choice of cisplatin or carboplatin). The primary hypothesis is that cosibelimab in combination with pemetrexed/platinum chemotherapy prolongs Overall Survival (OS) compared to pemetrexed/platinum chemotherapy alone.

NCT ID: NCT04775797 Terminated - Chronic Hepatitis Clinical Trials

Safety, Tolerability, and Pharmacokinetics of AB-836 in Healthy Subjects and Subjects With Chronic HBV Infection

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

This three-part, Phase 1 protocol will be the first clinical study of AB-836. Parts 1 and 2a/b will be a Phase 1a SAD/MAD of AB-836 in healthy adult subjects. Part 3 will be a Phase 1b dose-ranging assessment of AB-836 in non-cirrhotic Chronic Hepatitis B (CHB) subjects.

NCT ID: NCT04753658 Terminated - Neuroblastoma Clinical Trials

Real World Data Collection Pediatric Neuroblastoma Treated With Lorlatinib

Start date: March 19, 2021
Phase:
Study type: Observational

The overall goal of this real-world data collection is to assess demographic, clinical characteristics and real-world effectiveness of pediatric neuroblastoma patients treated with lorlatinib through the expanded access program.

NCT ID: NCT04745832 Terminated - Clinical trials for Non Hodgkin Lymphoma

Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)

Start date: August 13, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase 3 study of the PI3Kδ inhibitor Zandelisib (ME-401) in combination with rituximab, in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP) in subjects with relapsed or refractory FL and MZL.

NCT ID: NCT04730804 Terminated - Healthy Clinical Trials

A Study of ALXN1830 in Healthy Adult Participants

Start date: March 17, 2021
Phase: Phase 1
Study type: Interventional

This trial will study the effects of single and multiple doses of ALXN1830 in healthy adult participants.

NCT ID: NCT04718961 Terminated - Clinical trials for Intrahepatic Cholestasis of Pregnancy

A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA)

OHANA
Start date: January 4, 2021
Phase: Phase 2
Study type: Interventional

This is a two-part randomized study of volixibat in patients with Intrahepatic Cholestasis of Pregnancy (ICP) and elevated serum bile acid concentrations (sBA). Part 1 is an open-label study to evaluate safety and tolerability of two doses of volixibat. Part 2 is a double-blind, placebo controlled, study designed to evaluate the safety and efficacy of a selected volixibat dose.

NCT ID: NCT04639258 Terminated - Clinical trials for Aortic Valve Stenosis

Medtronic Evolut™ EXPAND TAVR I Feasibility Study

Start date: May 28, 2021
Phase: N/A
Study type: Interventional

The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™ PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis.