Hampton

Researchers are evaluating molnupiravir, a study medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 more effectively than a placebo. This Phase 3 randomized, placebo-controlled, double-blind study focuses on non-hospitalized adults at high risk of severe disease progression due to COVID-19. The study addresses the need for alternative treatments for people who cannot take certain COVID-19 medications due to availability or potential drug interactions. Participants will receive either molnupiravir or a placebo, both given orally as two 400 mg film-coated tablets every 12 hours for 5 days, totaling 10 doses. Some participants may also receive remdesivir as part of standard care if clinically appropriate and available. The study compares the effects of molnupiravir with placebo in preventing severe illness outcomes. Throughout the study, participants will be monitored for outcomes such as hospitalization, death, or medically attended visits related to COVID-19 up to 29 days. Safety is assessed by tracking adverse events for up to about 5 months and discontinuation of study treatment due to adverse events for about 5 days. The study involves laboratory tests, symptom assessments, and safety evaluations to understand molnupiravir's impact on disease progression and participant health.

Researchers are evaluating two forms of buprenorphine treatment for Veterans with moderate to severe opioid use disorder (OUD). This Phase 4, open-label, randomized controlled trial aims to compare a 28-day injectable subcutaneous buprenorphine formulation at a target dose of 300 mg with the standard daily sublingual buprenorphine dose ranging from 4 to 32 mg. The study will recruit 952 Veterans over seven years and follow them actively for 52 weeks, with additional passive follow-up via medical records for up to 10 years. The study also explores secondary outcomes including other substance use, overdose incidents, infections like HIV and hepatitis, incarceration, quality of life, mental health symptoms, housing, dental health, and cost-effectiveness. Participants will begin induction on daily sublingual buprenorphine using standard guidelines to reach a target dose between 4 and 32 mg within 45 days. After reaching this dose, participants are randomly assigned to either continue daily sublingual buprenorphine with naloxone, prescribed in 28-day take-home supplies, or receive monthly injectable buprenorphine administered in the clinic. Both treatment groups have visits at weeks 1, 2, 3, and 4 post-randomization, then every two weeks until week 52, with medication management provided at each visit. During the study, participants will provide self-reports of opioid abstinence and undergo urine drug screenings every two weeks. Medication adherence and retention in treatment are tracked approximately every four weeks. After the active 52-week period, participants will be followed passively through electronic medical records for up to 10 years to monitor long-term outcomes. This comprehensive approach aims to assess the effectiveness and safety of these treatments for opioid use disorder in Veterans.

Researchers are evaluating the effectiveness and safety of pirtobrutinib in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study focuses on two parts: Part 1 tests three different doses of pirtobrutinib in participants who have had 1 to 3 prior treatments, including a covalent Bruton tyrosine kinase (BTK) inhibitor. Part 2 evaluates pirtobrutinib alone in participants who have not received prior treatment but have a specific genetic deletion called 17p. This is a phase 2, open-label, randomized study. Pirtobrutinib is given orally to participants in both study parts. Participants in Part 1 receive one of three dose levels, while those in Part 2 receive pirtobrutinib monotherapy. Part 1 participation lasts about 3 years, and Part 2 participation can last up to 2 years. The study compares the effects of different doses and treatment histories to better understand pirtobrutinib’s impact on CLL/SLL. Throughout the study, researchers monitor participants' overall response to treatment from the start up to 3 years. They assess safety and side effects, and participants are required to be able to swallow oral medication and have a performance status that allows them to participate. The study includes regular evaluations to determine how well the treatment controls the disease and to track any adverse events over the course of the study periods.

Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of two different dose levels of solrikitug compared to placebo in people with Chronic Obstructive Pulmonary Disease (COPD). This Phase 2 study includes participants who have had COPD for at least 12 months and have elevated blood eosinophil levels. The trial aims to understand how solrikitug affects blood eosinophil counts and other health measures related to COPD. Participants will be randomly assigned to receive either low-dose solrikitug, high-dose solrikitug, or a placebo. These treatments are given by subcutaneous injection at the study site over a 12-week period. After treatment, there is a 16-week follow-up period to monitor participants for any lasting effects or safety concerns. During the study, participants will have regular assessments including lung function tests, blood tests to measure eosinophil counts, and evaluations of COPD symptoms. Researchers will monitor safety and tolerability closely throughout the treatment and follow-up periods. The total time commitment for participants covers the 12 weeks of treatment plus the 16 weeks of follow-up, totaling 28 weeks.

Researchers are evaluating a new medicine called PF-08634404 combined with chemotherapy for people aged 18 and older who have locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. The study includes participants who have not received prior treatment for advanced or metastatic disease and are in good health based on medical tests. This research is designed as a Phase 2/3 trial to learn about safety, response, and compare this new treatment to an approved therapy called nivolumab plus chemotherapy. The study has two parts: the first part assesses the safety and response to PF-08634404 with chemotherapy, and the second part compares this combination to nivolumab with chemotherapy. Treatments are given intravenously in repeated cycles. Participants receive either PF-08634404 plus chemotherapy or nivolumab plus chemotherapy based on the study phase and group assignment. During the study, participants undergo regular evaluations including medical tests to monitor organ function and safety. Researchers will measure treatment response using RECIST 1.1 criteria, track adverse events, and assess progression-free survival and overall survival over approximately four years. Follow-up continues through 90 days after the last treatment to monitor side effects and overall health.

Researchers are conducting a two-part, phase 2b/3 study to evaluate CSL300 (Clazakizumab) in adults with end stage kidney disease (ESKD) undergoing dialysis who have systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes. The study aims to determine the best dose of CSL300 and assess its effects on cardiovascular outcomes and safety in this population. This multicenter, randomized, double-blind, placebo-controlled trial targets patients with elevated inflammation markers and significant health risks due to their conditions. In the first part (phase 2b), the study focuses on finding the appropriate dose of CSL300 compared to placebo. CSL300 is given through intravenous (IV) administration. The second part (phase 3) evaluates the impact of CSL300 on cardiovascular events such as heart attack or cardiovascular death over approximately 5 years, continuing to compare CSL300 to placebo for safety and efficacy. The placebo matches CSL300's excipient content but lacks the active drug. Participants will undergo baseline and regular assessments for inflammation markers like high-sensitivity C-reactive protein (hs-CRP) up to 12 weeks in phase 2b, and long-term monitoring for cardiovascular outcomes in phase 3. The study involves ongoing safety evaluations and efficacy measurements during the entire follow-up period. This comprehensive approach helps researchers understand how CSL300 affects inflammation and cardiovascular health in patients with ESKD on dialysis.

Researchers are evaluating the effectiveness of Exposure and Response Prevention (ERP) therapy compared to a stress management training control in Veterans with Obsessive Compulsive Disorder (OCD), including those with both OCD and post-traumatic stress disorder (PTSD). This 4-year randomized clinical trial focuses on whether ERP can improve functioning, quality of life, and OCD symptoms among Veterans receiving care at various VA medical centers and telehealth hubs. Participants are randomly assigned to one of two groups: the ERP group receives 16 weekly therapy sessions delivered via video telehealth (VTH), emphasizing exposure to feared situations and prevention of compulsive rituals. The control group receives 16 weekly sessions of stress management training, which includes psychoeducation and skills such as deep breathing, relaxation, positive imagery, assertiveness, and problem solving. Both treatments include homework practice and symptom monitoring. Throughout the study, participants complete assessments at the end of treatment and six months later to measure changes in work and social functioning using the Work and Social Adjustment Scale (WSAS). Those in the ERP group also provide feedback on treatment satisfaction and participate in qualitative interviews about how the therapy affected their functioning and PTSD symptoms. Providers and VA administrators will also be interviewed to evaluate how ERP could be implemented in VA mental health care settings.

Researchers are evaluating the effects of two treatment approaches for men with intermediate risk prostate cancer. This phase III study aims to compare hypofractionated proton beam radiation therapy given alone versus combined with androgen suppression therapy. Proton therapy is a treatment option for localized prostate cancer, but the added benefit of androgen suppression is not fully known. Participants will receive proton radiation therapy, consisting of 28 treatments of 2.5 Gy (RBE) given five days a week over about 5.5 to 6.5 weeks, totaling 70 Gy (RBE). Some may receive high dose radiation with IMRT alone or intraoperative LDR brachytherapy combined with IMRT, depending on the treatment plan. The androgen suppression therapy involves hormone treatment starting 8 to 10 weeks before radiation and continuing for approximately 6 months. During the study, participants will be monitored for morbidity outcomes after at least three years of follow-up and then annually. Assessments include clinical evaluations, prostate-specific antigen (PSA) measurements, and performance status assessments. The study requires patients to complete pre-entry tests and start treatment within 56 days of randomization, with ongoing safety and treatment adherence monitoring throughout the trial.

Researchers are investigating the use of proton radiation therapy for women with early stage breast cancer. This study focuses on whether targeting radiation only to the area of the original tumor, instead of the whole breast, can be beneficial. The goal is to evaluate the safety, feasibility, and effectiveness of this approach compared to current standard treatments, which include mastectomy or whole breast irradiation after lumpectomy. Proton therapy may reduce side effects by limiting radiation exposure to healthy tissues. The study evaluates proton radiotherapy as a partial breast irradiation method. Participants will receive proton treatment targeted to the tumor region. This approach aims to lower radiation dose to normal breast tissue compared to conventional photon radiation. Treatment planning may involve the use of markers or clips in the surgical area to guide accurate radiation delivery. The study requires starting treatment within specific timeframes after surgery or chemotherapy. During the trial, participants will be monitored for breast cancer recurrence in the treated breast area over a period of three years. Safety and tumor control will be assessed through clinical exams, imaging, and pathology reports. Researchers will track any local recurrences and side effects related to the radiation therapy. The study requires follow-up to measure outcomes and ensure patient safety during and after treatment.

This research study aims to collect and analyze information from patients receiving different types of radiation therapy for neoplasms. The study focuses on tracking outcomes to better understand the effects of these treatments across participating institutions. Patients in this study will be treated with various forms of radiation therapy including proton therapy, photon therapy, stereotactic radiosurgery (SRS), and brachytherapy. The study involves prospective tracking of treatment outcomes without altering standard care procedures. Participants will have their treatment and health data recorded and monitored through chart reviews. Researchers will evaluate and define patient outcomes based on this collected information. Participation requires the ability to understand and sign consent, and there is no specified age or gender restriction for enrollment.