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NCT ID: NCT05164471 Terminated - Hemophilia B Clinical Trials

Phase 1/2 Dose Confirmation Study of FLT180a in Hemophilia B

Start date: December 6, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Study of FLT180a gene therapy in adults with Hemophilia B. Up to 9 patients will be enrolled to receive a single dose of FLT180a and be followed for 52 weeks. Results will confirm the dose for a future Phase 3 study.

NCT ID: NCT05162066 Terminated - Clinical trials for Membranous Nephropathy

Study to Evaluate the Safety, Tolerability of BCX9930 in Participants With Either Complement 3 Glomerulopathy (C3G), Immunoglobulin A Nephropathy (IgAN), or Primary Membranous Nephropathy (PMN)

RENEW
Start date: February 18, 2022
Phase: Phase 2
Study type: Interventional

The objective of this study was to determine the safety and therapeutic potential of BCX9930 in participants with C3G, IgAN, or PMN.

NCT ID: NCT05161936 Terminated - Clinical trials for Recurrent Calcium Oxalate Kidney Stone Disease

A Study to Evaluate Lumasiran in Adults With Recurrent Calcium Oxalate Kidney Stone Disease and Elevated Urinary Oxalate Levels

Start date: January 27, 2022
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to evaluate the effect of lumasiran on the percent change in urinary oxalate excretion in patients with recurrent calcium oxalate kidney stone disease.

NCT ID: NCT05161481 Terminated - Clinical trials for Hypertension, Portal

A Study to Test Whether Two Different Doses of Avenciguat Help People With Liver Cirrhosis and High Blood Pressure in the Portal Vein (Main Vessel Going to the Live

Start date: February 3, 2022
Phase: Phase 2
Study type: Interventional

This study is open to adults with liver cirrhosis and high blood pressure in the portal vein (main vessel going to the liver). The purpose of this study is to find out whether a medicine called Avenciguat helps people with this condition. Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of Avenciguat as tablets twice a day. Participants in the placebo group take placebo as tablets twice a day. Placebo tablets look like Avenciguat tablets but do not contain any medicine. Participants are in the study for about 8 months. During this time, they visit the study site about 14 times. At 3 of the visits, the doctors check the pressure in a liver vein. This is done with a catheter (a long thin tube) and gives information about the pressure in the portal vein. The change in blood pressure is then compared between the groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT05160558 Terminated - Clinical trials for Spinocerebellar Ataxia Type 3

A Pharmacokinetics and Safety Study of BIIB132 in Adults With Spinocerebellar Ataxia 3

Start date: February 2, 2022
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of multiple ascending doses of BIIB132 administered via intrathecal (IT) injection to participants with spinocerebellar ataxia type 3 (SCA3). The secondary objective of this study is to characterize the multiple-dose pharmacokinetics (PK) of BIIB132 administered via IT injection to participants with SCA3.

NCT ID: NCT05156229 Terminated - Clinical trials for Cutaneous T-cell Lymphoma (CTCL)

A Phase 1/2a Study of CDK-003 in Patients With Cutaneous T-Cell Lymphoma (CTCL).

Part B
Start date: September 6, 2021
Phase: Phase 1
Study type: Interventional

This is a Phase 1, dose escalation study to assess the safety, tolerability, pharmacokinetic and pharmacodynamic effects of CDK-003. The study is performed in two parts: Part A is a randomized, double-blind, placebo-controlled, single ascending dose study of CDK-003 in healthy adult male participants, and Part B is a single arm, open-label, multiple ascending dose in patient-participants with CTCL. Dose escalation in the study will only occur after satisfactory review of all available predefined data by the Safety Review Committee. Part A is complete and this entry describes Part B only.

NCT ID: NCT05154890 Terminated - Clinical trials for Homocystinuria Due to Cystathionine Beta-Synthase Deficiency

A Multiple Ascending Dose Study of ACN00177 (Pegtarviliase) in Subjects With CBS Deficiency

Start date: May 13, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of pegtarviliase in approximately 36 subjects with homocystinuria due to CBS deficiency.

NCT ID: NCT05137691 Terminated - Obesity Clinical Trials

Health After Birth Intervention Trial

HABIT
Start date: May 19, 2022
Phase: N/A
Study type: Interventional

This trial is to assess the feasibility of a larger, definitive RCT and determine the clinical effectiveness of an NHS 1:1 programme versus a modified programme with a low carbohydrate dietary intervention (as per Feinman and colleagues classification) with telehealth, physical activity and enhanced behaviour change on specified health outcomes amongst post-partum women living with obesity

NCT ID: NCT05132569 Terminated - Myasthenia Gravis Clinical Trials

Efficacy and Safety of Tolebrutinib (SAR442168) Tablets in Adult Participants With Generalized Myasthenia Gravis

URSA
Start date: December 3, 2021
Phase: Phase 3
Study type: Interventional

This was a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of tolebrutinib compared with placebo in adult participants aged 18 to 85 years old with moderate-to-severe generalized myasthenia gravis (gMG), who received Standard of Care (SoC). The double-blind (DB) treatment period of 26 weeks comprised of 7 site visits followed by a 2-year open label extension (OLE) period with quarterly visits. The efficacy of tolebrutinib versus placebo during the DB period was assessed by clinical evaluations, including scales based on physician examination or direct participant feedback i.e., patient reported outcomes (PROs). These evaluations continued during the OLE to measure long term efficacy and safety.

NCT ID: NCT05129280 Terminated - Solid Tumors Clinical Trials

A Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-tumor Activity of RO7444973 in Participants With Unresectable and/or Metastatic MAGE-A4-positive Solid Tumors

Start date: January 25, 2022
Phase: Phase 1
Study type: Interventional

This is a first-in-human, open-label, uncontrolled, multi-center, monotherapy dose-escalation and dose expansion study of RO7444973.The aim of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of RO7444973 in participants with unresectable and/or metastatic melanoma-associated antigen A4 (MAGE-A4)-positive, solid tumors, carrying the HLA-A*02:01 allele.