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NCT ID: NCT04460768 Completed - Ovarian Neoplasms Clinical Trials

An INternational Frontline Ovarian Cancer Real World Management Study

INFORM
Start date: June 27, 2020
Phase:
Study type: Observational

The current study aims to analyze the existing secondary databases from Korea (Sungkyunkwan University, Samsung Medical Center, Seoul), Taiwan (National Taiwan University, Chang-Gung Medical Foundation Linkou Branch and Mackay Memorial Hospital), and Australia (Australian Ovarian Cancer Study [AOCS]) to leverage the already available data in the real-world setting to review the current standard of care in advanced epithelial ovarian cancer cases. The collected data will help provide the required information for assessing the unmet treatment needs in this patient group. The data will also provide the needed information to support any reimbursement activity needed for future novel therapies in this patient group

NCT ID: NCT04458805 Completed - Ulcerative Colitis Clinical Trials

Safety, Tolerability and Pharmacokinetics of Oral NX-13 in Healthy Adults Male and Female Volunteers

Start date: July 10, 2020
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study. The study will be conducted in 2 parts: a single ascending dose (SAD) part (Part A) followed by a multiple ascending dose (MAD) part (Part B). The decision to escalate between dose levels and proceed to Part B will be based upon review of blinded available safety data by a Safety Review Committee.

NCT ID: NCT04456998 Completed - Clinical trials for Pulmonary Artery Hypertension

GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)

Start date: November 12, 2020
Phase: Phase 2
Study type: Interventional

The primary objective for this trial is to determine the effect of GB002 (seralutinib) on improving pulmonary hemodynamics in subjects with World Health Organization (WHO) Group 1 PAH who are Functional Class (FC) II and III. The secondary objective for this trial is to determine the effect of GB002 (seralutinib) on improving exercise capacity in this population.

NCT ID: NCT04456699 Completed - Clinical trials for Metastatic Colorectal Cancer

Efficacy and Safety of Olaparib (MK-7339) With or Without Bevacizumab Compared to Bevacizumab With a Fluoropyrimidine in Unresectable or Metastatic Colorectal Cancer (CRC) (MK-7339-003/LYNK-003)

Start date: August 19, 2020
Phase: Phase 3
Study type: Interventional

This is an efficacy and safety study of olaparib alone or in combination with bevacizumab being compared to bevacizumab with a fluoropyrimidine in participants with unresectable or metastatic colorectal cancer who have not progressed following first-line induction. The primary hypotheses are: Olaparib + Bevacizumab is superior to a fluoropyrimidine + Bevacizumab with respect to progression-free survival (PFS) using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR); Olaparib is superior to a fluoropyrimidine + Bevacizumab with respect to PFS using RECIST 1.1 as assessed by BICR. As of amendment 5 study enrollment is being discontinued and study participants randomized to one of the two experimental arms (olaparib plus bevacizumab or olaparib monotherapy) must discontinue study intervention. Participants who are still on study treatment will no longer have tumor response assessments by BICR.

NCT ID: NCT04456634 Completed - Malaria Clinical Trials

Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of Ruxolitinib With Artemether-lumefantrine

Start date: September 10, 2020
Phase: Phase 1
Study type: Interventional

Phase 1, single -center study in 2 parts. The study designs for each part are well established for first-in-human studies and are appropriate to assess safety, tolerability and preliminary pharmacokinetics& pharmacodynamics.

NCT ID: NCT04454229 Completed - Clinical trials for Hypersensitivity, Immediate

The Use of Penicillin Allergy Clinical Decision Rule to Enable Direct Oral Penicillin Challenge

PALACE
Start date: July 1, 2021
Phase: N/A
Study type: Interventional

Whilst validated tools exist to enable inpatient penicillin assessment and de-labelling, limited evidence is available regarding the safety and efficacy in the outpatient clinic. The ability to deliver point-of-care penicillin allergy testing for a large cohort of patients, without skin testing, will improve patient access to testing and utilization of preferred penicillin antibiotics.

NCT ID: NCT04453852 Completed - COVID Clinical Trials

Monovalent Recombinant COVID19 Vaccine

COVAX19
Start date: June 30, 2020
Phase: Phase 1
Study type: Interventional

This is a study to test a new vaccine (Covax-19) against COVID-19. COVID-19 is a potentially deadly disease that is caused by a new strain of coronavirus called SARS-CoV-2. To date, SARS-CoV-2 has infected over 4 million people worldwide resulted in the deaths of over three hundred thousand people.

NCT ID: NCT04451772 Completed - Clinical trials for Systemic Lupus Erythematosus (SLE)

A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Participants With Moderately to Severely Active Systemic Lupus Erythematosus to Assess Change in Disease State

Start date: July 27, 2020
Phase: Phase 2
Study type: Interventional

Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will evaluate how well elsubrutinib and upadacitinib given alone or as the ABBV-599 combination (elsubrutinib/upadacitinib) works within the body, in participants who completed study M19-130. This study will assess the change in disease symptoms. ABBV-599 is an investigational drug being developed for the treatment of Systemic Lupus Erythematosus (SLE). This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants into 1 of 4 groups called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of SLE will be enrolled. Around 260 participants will be enrolled in the study in approximately 100 sites worldwide. Participants will receive the following for up to 56 weeks: Participants will receive oral elsubrutinib capsules and/or oral upadacitinib tablets once daily for up to 56 weeks. Participants who were receiving elsubrutinib and/or upadacitnib in M19-130 will continue to receive the same treatment in this study. Participants who were receiving placebo in M19-130 will be re-randomized to one of the 2 combination treatment arms in this study. Arm 1: Elsubrutinib Dose A and Upadacitinib Dose A Arm 2: Elsubrutinib Dose A and Upadacitinib Dose B There may be higher burden for participants in this trial compared to their standard of care. Participants will attend monthly visits during the course of 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: NCT04451434 Completed - Healthy Clinical Trials

Study of Danicopan in Participants of Japanese Descent

Start date: August 17, 2020
Phase: Phase 1
Study type: Interventional

This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of danicopan after a single-dose oral administration under fed and fasting conditions to participants of Japanese descent.

NCT ID: NCT04444752 Completed - Clinical trials for Moderate-to-severe Atopic Dermatitis

A Study to Assess the Efficacy and Safety of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis

Start date: July 17, 2020
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of CBP-201 in adult subjects with moderate to severe atopic dermatitis.