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NCT ID: NCT03563053 Recruiting - Clinical trials for Ataxia Telangiectasia

Open-label, Long-term, Extension Treatment Using Intra-Erythrocyte Dexamethasone Sodium Phosphate in Patients With Ataxia Telangiectasia Who Participated in the IEDAT-02-2015 Study

OLE-IEDAT
Start date: June 12, 2018
Phase: Phase 3
Study type: Interventional

This is an international (North America, Europe, Africa, Asia and Australia), multi-center, prospective, open-label treatment study, designed to continue to provide the study medication to all patients who completed 12 months of treatment (including those treated with placebo) in the IEDAT-02-2015 trial, completed the study assessments, do not present safety contraindication to continuation of treatment, and provided informed consent. The study aims to collect information on the long-term safety and efficacy of the trial treatment.

NCT ID: NCT03562637 Recruiting - Clinical trials for Triple Negative Breast Cancer

Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC

Start date: December 5, 2018
Phase: Phase 3
Study type: Interventional

The GLORIA study is a Phase III, randomized, open-label study to prospectively evaluate the efficacy and safety of adagloxad simolenin (OBI 822)/OBI-821 in the adjuvant treatment of patients with high risk, early stage Globo-H Positive TNBC.

NCT ID: NCT03557619 Recruiting - Clinical trials for Hematologic Malignancies

A Study to Assess the Effect of Venetoclax on Ethinyl Estradiol and Levonorgestrel in Female Participants With Different Hematological Malignancies

Start date: July 30, 2019
Phase: Phase 1
Study type: Interventional

A study to assess the effect of multiple doses of venetoclax on the pharmacokinetics of ethinyl estradiol and levonorgestrel in female participants with different hematological malignancies. Upon completion of this study, participants receiving clinical benefit in the opinion of the investigator and without any clinically significant evidence of disease progression with no access to venetoclax (not approved for the treated indication) may continue receiving venetoclax at the discretion of the investigator in a separate extension study.

NCT ID: NCT03537482 Recruiting - Clinical trials for Hematologic Malignancies

APG-2575 Study of Safety, Tolerability ,PK/PD in Patients With Hematologic Malignancies

Start date: August 7, 2018
Phase: Early Phase 1
Study type: Interventional

This is a multi-center, single-agent, open-label, Phase I study of APG-2575. The study consists of the dose escalation stage and the dose expansion stage.

NCT ID: NCT03534947 Recruiting - Skin Cancer Clinical Trials

A Study to Evaluate Neoadjuvant Sonidegib Followed by Surgery or Imiquimod in the Management of Basal Cell Carcinoma

SONIB
Start date: July 23, 2019
Phase: Phase 2
Study type: Interventional

In this study, patients with BCC will be given neoadjuvant treatment with a drug called sonidegib. Sonidegib is a daily tablet usually given for BCC that cannot be removed by surgery or that has spread through the body. The study aims to see if sonidegib given for 12 weeks will reduce the size of tumours so surgery results in less scarring or may be avoided, with only short term topical treatment required to treat remaining tumour.

NCT ID: NCT03529526 Recruiting - Clinical trials for Advanced Solid Tumors

Study of the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Antitumor Activity of KN046 in Subjects With Advanced Solid Tumors

Start date: May 21, 2018
Phase: Phase 1
Study type: Interventional

This is an open-label, multicenter, dose-escalation phase I study to assess the safety, tolerability and preliminary efficacy of KN046 in participants with all advanced solid tumors who are not able to have current standard anti-tumor therapies. The purpose of this study is to determine the maximum tolerated dose (MTD) or a biological effective dose (BED), to characterise the safety, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of KN046 as a single agent in adult participants with advanced solid tumors

NCT ID: NCT03522064 Recruiting - Clinical trials for Castration-resistant Prostate Cancer

Bipolar Androgen Therapy + Carboplatin in mCRPC

HiTeCH
Start date: July 30, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the efficacy of BAT and carboplatin in men with metastatic castrate-resistant prostate cancer (mCRPC).

NCT ID: NCT03519945 Recruiting - Ulcerative Colitis Clinical Trials

A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)

Start date: July 18, 2018
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC). The study will last up to 3 years. Participants who complete the 3-year study may continue to receive mirikizumab until it is (outside of this study) in their country or until they meet other discontinuation criteria.

NCT ID: NCT03508141 Recruiting - Trauma Clinical Trials

Fibrinogen Early In Severe Trauma studY Junior

FEISTY Jnr
Start date: July 1, 2018
Phase: Phase 2
Study type: Interventional

1. Haemorrhage in severe trauma is a significant cause of mortality and is potentially the most preventable cause of death in paediatric trauma patients 2. Trauma Induced Coagulopathy (TIC) is a complex coagulopathy associated with severe trauma 3. Hypo/dysfibrinogenaemia plays an important role in TIC 4. Early replacement of fibrinogen may improve outcomes 5. Fibrinogen replacement is potentially inadequate in standard fixed ratio Major Haemorrhage Protocols (MHP) utilising Plasma and/or Cryoprecipitate 6. The majority of centres utilise cryoprecipitate for additional fibrinogen supplementation as part of a MHP 7. Cryoprecipitate administration is often delayed (between 60 - 120 minutes) in a fixed ratio MHP 8. It is clear early intervention in severe traumatic haemorrhage is associated with improved outcomes - CRASH 2 and PROPPR studies 9. Increasing interest in the use of Fibrinogen Concentrate (FC) in severe bleeding but not supported by high level evidence 10. Benefits of FC - viral inactivation, known dose, easily reconstituted, can be administered quickly in high dose and stored at room temperature in the trauma resuscitation bay 12. No previous studies comparing FC and Cryoprecipitate in bleeding paediatric trauma patients 13. Fibrinogen supplementation will be guided by an accepted ROTEM targeted treatment algorithm 14. Pilot, multi-centre randomised controlled trial comparing FC to Cryoprecipitate (current standard practise in fibrinogen supplementation) 15. Hypothesis: Fibrinogen replacement in severe traumatic haemorrhage can be achieved quicker with a more predictable dose response using Fibrinogen Concentrate compared to Cryoprecipitate 16. It is imperative that robust and clinically relevant trials are performed to investigate fibrinogen supplementation in paediatric trauma patients before widespread adoption makes performing such studies unfeasible

NCT ID: NCT03505229 Recruiting - Clinical trials for High Risk Localised Pancreatic Cancer

Span-C-SBRT for Pancreatic Cancer

Span-C
Start date: December 18, 2018
Phase: N/A
Study type: Interventional

To assess the freedom from local failure at 12 months after Stereotactic Body Radiotherapy (SBRT). Also to assess the safety, efficacy and feasibility of SBRT in the treatment of high risk localised pancreatic cancer.