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NCT ID: NCT05007977 Terminated - Type 1 Diabetes Clinical Trials

Effect of ZT-01 on Glucagon During Hypoglycemia in Type 1 Diabetes Mellitus

Start date: July 8, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine whether ZT-01 increases the glucagon response to hypoglycemia in type 1 diabetes (T1D). ZT-01 is a specific somatostatin (SST) type 2 receptor antagonist hypothesized to increase the counterregulatory glucagon release during hypoglycemia, which is impaired in diabetes, and may thus reduce the occurrence of hypoglycemia. Approximately 25 participants with well-controlled type 1 diabetes will be recruited to a crossover study and be randomized to the order in which they receive a single administration of placebo, low dose and high dose ZT-01 during three euglycemic-hypoglycemic clamps 2 to 6 weeks apart, with a follow-up visit approximately 1 week after the final clamp. Participants will stay overnight in the clinic before each clamp, and their plasma glucose (PG) will be kept at euglycemic levels with IV insulin and dextrose as needed. The following morning, the clamp will begin and the subject's PG will be kept at 5.5 mmol/L (euglycemia) with variable IV insulin (and dextrose as needed). Study treatment will be administered during this euglycemic period, and then insulin will be increased so that PG falls to a plateau of mild hypoglycemia, and then increased further to clinically significant hypoglycemia. Release of glucagon and other counterregulatory hormones will be measured, and a symptom score will be completed, during euglycemia before and following study treatment, and during each level of hypoglycemia. Following the clamp, the participant's blood glucose will be returned to normal levels prior to leaving the clinic.

NCT ID: NCT05005507 Terminated - Clinical trials for Hepatitis B, Chronic

A Study of JNJ-73763989, Pegylated Interferon Alpha-2a and Nucleos(t)Ide Analogs in Participants With Chronic Hepatitis B Virus Infection

PENGUIN-2
Start date: November 3, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy in terms of hepatitis B surface antigen (HBsAg) changes from baseline for the treatment regimens of 24 weeks of JNJ-73763989 + 24 weeks of nucleos(t)ide analog (NA) + 12 or 24 weeks of pegylated interferon alpha-2a (PegIFN-alpha-2a) (with immediate or delayed start of PegIFN-alpha-2a treatment).

NCT ID: NCT04992845 Terminated - Clinical trials for Adolescent Idiopathic Scoliosis

Fusionless Treatment of Idiopathic Scoliosis With the SCOLI-TETHER System During The Growth Period

FUTURE
Start date: April 15, 2019
Phase: N/A
Study type: Interventional

The goal of the study is to establish the safety and benefit of treatment of juvenile and adolescent idiopathic scoliosis (AIS) with the SCOLI-TETHER (MIScoli) System.

NCT ID: NCT04988308 Terminated - Clinical trials for Hidradenitis Suppurativa

A Study of Bermekimab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa

LYRA
Start date: October 12, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the clinical efficacy of bermekimab in participants with moderate to severe Hidradenitis Suppurativa (HS).

NCT ID: NCT04987944 Terminated - Asthma Clinical Trials

Safety and Efficacy Active Drug vs. Placebo in Subjects With Asthma

Start date: October 18, 2021
Phase: Phase 1
Study type: Interventional

This study is a double-blind, parallel-group, randomized study of active drug vs placebo in asthma.

NCT ID: NCT04985968 Terminated - Ulcerative Colitis Clinical Trials

The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis

CONCLUDE
Start date: November 24, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy of cobitolimod treatment compared to placebo in inducing clinical remission, in participants with moderate to severe active left-sided UC and to evaluate the efficacy of cobitolimod maintenance treatment compared to placebo in inducing or maintaining clinical remission at week 52, in participants with clinical response at week 6 after induction treatment with cobitolimod.

NCT ID: NCT04984876 Terminated - Allergy, Peanut Clinical Trials

Efficacy and Safety of QGE031 (Ligelizumab) in Patients With Peanut Allergy

Start date: December 7, 2021
Phase: Phase 3
Study type: Interventional

This is a 52-week, Phase 3 multi-center, randomized, double-blind and placebo-controlled study to assess the safety and clinical efficacy of two dosing regimens of ligelizumab (240 mg and 120 mg) subcutaneous injection every 4 weeks (SCq4w) in participants with a medically confirmed diagnosis of IgE-mediated peanut allergy.

NCT ID: NCT04981717 Terminated - Clinical trials for Allergic Rhinitis Due to Cat Allergy

A Study to Examine the Efficacy and Safety of Anti-Fel d 1 Antibodies Injections in Cat-allergic Adolescent and Adult Patients With Allergic Rhinitis Who Live With a Cat

Start date: July 30, 2021
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to determine the efficacy of REGN1908-1909, as compared to placebo, to reduce allergic rhinitis/conjunctivitis symptoms and allergy rescue medication use during natural cat exposure. The Secondary Objectives are: - To assess the reduction of allergic symptoms and use of allergy rescue medications after treatment with REGN1908-1909 versus placebo, as measured by the individual components of the CSMS - To assess health-related quality of life (HRQoL) as measured by the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ[S]) - To determine the efficacy of REGN1908-1909, as compared to placebo, to inhibit a wheal-and-flare response to a skin prick test with cat allergen - To assess the durability of effect in allergic rhinitis and conjunctivitis symptom and medication scores after multiple doses of REGN1908-1909 compared to placebo given every 12 weeks (Q12W) - To determine the efficacy following multiple doses of REGN1908-1909 compared to placebo at inhibiting a wheal-and-flare response to a skin prick test with cat allergen - To estimate the effect of REGN1908-1909 on lung function, as compared to placebo, in patients with asthma - To determine the efficacy of REGN1908-1909 as compared to placebo to reduce asthma symptoms in patients with asthma - To assess whether there is a difference in asthma rescue medication use in patients with asthma who are treated with REGN1908-1909 compared to placebo - To assess whether there is a difference in nighttime awakenings in patients with asthma treated with REGN1908-1909 compared to placebo - To evaluate the short-term and long-term safety and tolerability of REGN1908-1909, including the incidence of hypersensitivity reactions, local injection site reactions, and asthma exacerbations - To determine systemic exposure of total (free and antigen-bound) antibodies as measured by concentration of REGN1908 and REGN1909 - To assess the immunogenicity of REGN1908 and REGN1909

NCT ID: NCT04980391 Terminated - Clinical trials for Respiratory Syncytial Virus Infections

A Study on the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine, in High Risk Pregnant Women Aged 15 to 49 Years and Infants Born to the Vaccinated Mothers

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

The purpose of this study was to evaluate the safety, reactogenicity and immune response of a single intramuscular dose of the respiratory syncytial virus (RSV) maternal vaccine compared to placebo, when administered in the second or third trimester of pregnancy in women, 15 to 49 years of age (YOA), with high risk pregnancies and in the infants born to the vaccinated mothers. Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study. Ongoing study participants at that time continued to be monitored as part of the study.

NCT ID: NCT04979442 Terminated - Clinical trials for Dedifferentiated Liposarcoma

Treatment of Milademetan Versus Trabectedin in Patient With Dedifferentiated Liposarcoma

MANTRA
Start date: July 14, 2021
Phase: Phase 3
Study type: Interventional

Randomized, multicenter, open-label, Phase 3 registration study designed to evaluate the safety and efficacy of milademetan compared to trabectedin in patients with unresectable (i.e., where resection is deemed to cause unacceptable morbidity or mortality) or metastatic DD liposarcoma that progressed on 1 or more prior systemic therapies, including at least 1 anthracycline-based therapy.