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NCT ID: NCT05179876 Recruiting - Clinical trials for Hypertension, Pulmonary

A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option

PLATYPUS
Start date: May 4, 2022
Phase: Phase 3
Study type: Interventional

The purpose of the study is to enable participants with pulmonary hypertension (PH) currently treated with study intervention(s) in a clinical study (parent studies [NCT03422328, NCT03904693 and NCT04565990]), to continue to benefit from the intervention after closure of the parent study in case they have no alternative means of access to the study intervention. This study will allow assessment of the long-term safety of each study intervention.

NCT ID: NCT05175794 Recruiting - Tuberculosis Clinical Trials

Triage Test for All Oral DR-TB Regimen (TRiAD Study)

Start date: May 26, 2022
Phase:
Study type: Observational

A Phase 4 operational study to assess the effectiveness, feasibility, acceptability, and cost effectiveness of the GeneXpert MTB/XDR (Xpert XDR; Cepheid) assay for rapid triage-and-treatment of DR-TB-A multi-centre, multi-country prospective cohort study

NCT ID: NCT05161195 Recruiting - Clinical trials for Metastatic Breast Cancer

Roll-over Study to Allow Continued Access to Ribociclib

Start date: July 7, 2022
Phase: Phase 4
Study type: Interventional

This is an open-label, multi-center, roll-over study to evaluate the long term safety of ribociclib in combination with other drugs in participants who are participating in a Novartis sponsored global study, that has fulfilled requirements for its primary objective(s), and who in the opinion of the Investigator, would benefit from continued treatment.

NCT ID: NCT05156281 Recruiting - Clinical trials for Relapsing Multiple Sclerosis

Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)

REMODEL-2
Start date: December 13, 2021
Phase: Phase 3
Study type: Interventional

To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS)

NCT ID: NCT05154513 Recruiting - HIV Infection Clinical Trials

Long-Term Clinical, Immunologic, and Virologic Profiles of Children Who Received Early Treatment for HIV

Start date: February 2, 2022
Phase:
Study type: Observational

IMPAACT 2028 is an observational prospective study to characterize a cohort of early treated children who may participate in future research related to HIV remission or cure. Up to approximately 250 participants will be in the study for approximately seven years. No intervention is provided in the study.

NCT ID: NCT05152147 Recruiting - Clinical trials for Esophageal Adenocarcinoma

A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers

HERIZON-GEA-01
Start date: December 2, 2021
Phase: Phase 3
Study type: Interventional

This study is being done to find out if zanidatamab, when given with chemotherapy plus or minus tislelizumab, is safe and works better than trastuzumab given with chemotherapy. The patients in this study will have advanced human epidermal growth factor 2 (HER2)-positive stomach and esophageal cancers that are no longer treatable with surgery (unresectable) or chemoradiation, and/or have grown or spread to other parts of the body (metastatic).

NCT ID: NCT05148845 Recruiting - Clinical trials for SARS CoV 2 Infection

Sisonke 2 - A COVID-19 Vaccine Boost Open Label Study.

Sisonke Boost
Start date: November 10, 2021
Phase: Phase 3
Study type: Interventional

To evaluate the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine plus a homologous boostwith Ad26.COV2.S COVID-19 vaccine among Sisonke participants as compared to unboosted Sisonkeparticipants; vaccinated; and unvaccinated populations in South Africa

NCT ID: NCT05145127 Recruiting - Hemophilia A Clinical Trials

Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors

Start date: November 17, 2021
Phase: Phase 3
Study type: Interventional

Study B7841007 is an open-label extension study to assess the long-term safety, tolerability, and efficacy of prophylaxis treatment with marstacimab in participants who did not require "Early Termination" from the Phase 3 Study B7841005 and from the Phase 3 Study B7841008. Study B7841005: approximately 145 adolescent and adult participants 12 to <75 years of age with severe hemophilia A or moderately severe to severe hemophilia B (defined as FVIII activity <1% or FIX activity ≤2%, respectively) with or without inhibitors are expected to be enrolled in Study B7841005 during which they will receive prophylaxis (defined as treatment by SC injection of marstacimab). Study B7841008: this is an ongoing Phase 3, open-label study in pediatric participants <18 years of age with severe hemophilia A (FVIII Coagulation Factor Activity <1%) or moderately severe to severe hemophilia B (FIX Coagulation Factor Activity ≤2%). A sequential approach will be used in enrolling at least 100 pediatric participants, at least 20 of which will be aged ≥12 to <18 years and at least 80 participants will be aged ≥1 to <12 years. At the start of study B7841008, the dosing and data available in adolescent and adult participants in Study B7841005 supported the initiation of B7841008 study in participants aged ≥12 to <18 years. Subsequently, additional safety and efficacy data from adolescent participants in Study B7841005 became available for benefit/risk assessment in support of dosing participants aged ≥6 to <12 years. Based on the positive benefit/risk assessment conducted by both internal Pfizer review and eDMC review, dosing of the ≥6 to <12 years age group was initiated in June 2023 in B7841008 Study. Data from participants ≥6 years from B7841008 Study and Study B7841005 will support the dosing of participants aged ≥1 to <6 years. All participants will be provided the prefilled pen (PFP) for administration of marstacimab in the study. Use of the prefilled syringe (PFS) will be permitted at the investigator's discretion for those participants who have difficulty with administration of the PFP. Additionally, participants will be provided the PFS for use in this study in countries where the PFS is anticipated to be the only presentation available commercially. An optional, open-label, single arm, substudy using the PFP was completed in the first 23 participants rolled over from Study B7841005 who agreed to participate in the substudy.

NCT ID: NCT05137119 Recruiting - Clinical trials for Staphylococcus Aureus Bacteremia

Staphylococcus Aureus Network Adaptive Platform Trial

SNAP
Start date: February 16, 2022
Phase: Phase 4
Study type: Interventional

The Staphylococcus aureus Network Adaptive Platform (SNAP) trial is an International Multi-Centered Randomised Adaptive Platform Clinical Trial to evaluate a range of interventions to reduce mortality for patients with Staphylococcus Aureus bacteraemia (SAB).

NCT ID: NCT05135559 Recruiting - Clinical trials for Haemophilia A and B With and Without Inhibitors

A Research Study on How Well Concizumab Works for You if You Have Haemophilia A or B With or Without Inhibitors

Explorer10
Start date: March 24, 2022
Phase: Phase 3
Study type: Interventional

This study will test how well a new medicine called concizumab works for participants who have haemophilia A or B with or without inhibitors. The purpose is to show that concizumab can prevent bleeds and is safe to use. Participants will have to inject the study medicine every day under the skin with a pen-injector. The study will last for at least 2 years and up to about 4 years. The length of time the participant will be in the study depends on if the study medicine will be available for purchase in their country.