Evaluation of the safety and effectiveness of intradermal administration of QR678 Neo ® hair growth factor formulation: A phase‐IV, open‐label, single‐arm multi‐ethnicity clinical trial

2022 ◽  
Author(s):  
Aayna Clinic ◽  
Annette Asper ◽  
Apoorva Mittal ◽  
Debraj Shome ◽  
Deepa Parbhoo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Growth Factor ◽  
Hair Growth ◽  
Open Label ◽  
Intradermal Administration ◽  
Phase Iv

scholarly journals Proteomic Analysis of Sera from Individuals with Diffuse Cutaneous Systemic Sclerosis Reveals a Multianalyte Signature Associated with Clinical Improvement during Imatinib Mesylate Treatment

2017 ◽  
Vol 44 (5) ◽  
pp. 631-638 ◽  
Author(s):  
D. James Haddon ◽  
Hannah E. Wand ◽  
Justin A. Jarrell ◽  
Robert F. Spiera ◽  
Paul J. Utz ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Systemic Sclerosis ◽  
Growth Factor ◽  
Clinical Improvement ◽  
Transforming Growth Factor ◽  
Kinase Inhibitor ◽  
Transforming Growth Factor Β ◽  
Elastic Net ◽  
Open Label ◽  
Link Type

Objective.Imatinib has been investigated for the treatment of systemic sclerosis (SSc) because of its ability to inhibit the platelet-derived growth factor receptor and transforming growth factor-β signaling pathways, which have been implicated in SSc pathogenesis. In a 12-month open-label clinical trial assessing the safety and efficacy of imatinib in the treatment of diffuse cutaneous SSc (dcSSc), significant improvements in skin thickening were observed. Here, we report our analysis of sera collected during the clinical trial.Methods.We measured the levels of 46 cytokines, chemokines, and growth factors in the sera of individuals with dcSSc using Luminex and ELISA. Autoantigen microarrays were used to measure immunoglobulin G reactivity to 28 autoantigens. Elastic net regularization was used to identify a signature that was predictive of clinical improvement (reduction in the modified Rodnan skin score ≥ 5) during treatment with imatinib. The signature was also tested using sera from a clinical trial of nilotinib, a tyrosine kinase inhibitor that is structurally related to imatinib, in dcSSc.Results.The elastic net algorithm identified a signature, based on levels of CD40 ligand, chemokine (C-X-C motif) ligand 4 (CXCL4), and anti-PM/Scl-100, that was significantly higher in individuals who experienced clinical improvement than in those who did not (p = 0.0011). The signature was validated using samples from a clinical trial of nilotinib.Conclusion.Identification of patients with SSc with the greatest probability of benefit from treatment with imatinib has the potential to guide individualized treatment. Validation of the signature will require testing in randomized, placebo-controlled studies. Clinicaltrials.govNCT00555581 and NCT01166139.

scholarly journals Open-label phase IV clinical trial to evaluate the effect of nasal testosterone gel on reproductive hormones and semen parameters in hypogonadal men

2019 ◽  
Vol 112 (3) ◽  
pp. e434-e435
Author(s):  
Thomas A. Masterson ◽  
Joshua N. Bitran ◽  
Manuel Molina ◽  
Emad Ibrahim ◽  
Ursula Kaiser ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Reproductive Hormones ◽  
Semen Parameters ◽  
Open Label ◽  
Testosterone Gel ◽  
Open Label Phase ◽  
Phase Iv

Subcutaneous insulin-like growth factor-1 treatment in spinocerebellar ataxias: An open label clinical trial

2010 ◽  
Vol 26 (2) ◽  
pp. 358-359 ◽  
Author(s):  
Javier Arpa ◽  
Irene Sanz-Gallego ◽  
Josmarlin Medina-Báez ◽  
Luis Valmor Cruz Portela ◽  
Laura Bannach Jardim ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Growth Factor ◽  
Insulin Like Growth Factor ◽  
Subcutaneous Insulin ◽  
Spinocerebellar Ataxias ◽  
Open Label

scholarly journals Nicardipine Hydrochloride Injectable Phase IV Open-Label Clinical Trial: Study on the Anti-Hypertensive Effect and Safety of Nicardipine for Acute Aortic Dissection

2002 ◽  
Vol 30 (3) ◽  
pp. 337-345 ◽  
Author(s):  
KH Kim ◽  
IS Moon ◽  
JS Park ◽  
YB Koh ◽  
H Ahn
Keyword(s):  
Blood Pressure ◽  
Clinical Trial ◽  
Aortic Dissection ◽  
Acute Aortic Dissection ◽  
Open Label ◽  
Multicentre Phase ◽  
The Third ◽  
Arterial Blood ◽  
Blood Pressures ◽  
Phase Iv

We performed a multicentre, phase IV, open-label clinical trial to examine the clinical usefulness of a continuous infusion of nicardipine hydrochloride to control hypertension in 31 patients with acute aortic dissection. Target blood pressure levels were reached within 15 min in 16 patients; in 15–30 min in 10 patients; in 30–45 min in three patients; and in 45–60 min in two patients. Baseline average systolic, diastolic and mean arterial blood pressures were 147 ± 23 mmHg, 82 ± 18 mmHg and 104 ± 18 mmHg, respectively, with third-day pressures significantly reduced at 119 ± 12 mmHg, 69 ± 9 mmHg and 86 ± 8 mmHg. Blood pressures after discontinuation of the infusion were not significantly different from those measured on the third day of infusion and no definite adverse effects attributable to the treatment were observed. Nicardipine hydrochloride was both effective and safe at controlling blood pressure in patients with acute aortic dissection.

scholarly journals Comparison of safety and efficacy of dextromethorphan and levocloperastine in treatment of dry cough: a randomized open label phase IV clinical trial

2019 ◽  
Vol 8 (10) ◽  
pp. 2284
Author(s):  
Arijit Ghosh
Keyword(s):  
Clinical Trial ◽  
Selection Criteria ◽  
Open Label ◽  
Safety And Efficacy ◽  
Leicester Cough Questionnaire ◽  
Open Label Phase ◽  
Group A ◽  
Group B ◽  
Phase Iv

Background: To compare safety and efficacy of dextromethorphan and levocloperastine in treatment of dry cough.Methods: Patients fulfilling the selection criteria were randomized into two groups. Patients in group A were administered dextromethorphan cough lozenges (5 mg) thrice daily for 7 days. Patients in group B were administered syrup levocloperastine (20 mg/5 ml) 5 ml thrice daily for 7 days. Severity and frequency of cough, and Leicester Cough Questionnaire (LCQ) score were assessed at the end of day 7.Results: Levocloperastine significantly decreased (p<0.5) severity and frequency of cough compared to dextromethorphan at day 7. Levocloperastine also significantly increased LCQ score compared to dextromethorphan at day 7.Conclusions: Levocloperastine is significantly more effective compared to dextromethorphan in treatment of dry cough. 

scholarly journals FG-3019 anti-connective tissue growth factor monoclonal antibody: results of an open-label clinical trial in idiopathic pulmonary fibrosis

2016 ◽  
Vol 47 (5) ◽  
pp. 1481-1491 ◽  
Author(s):  
Ganesh Raghu ◽  
Mary Beth Scholand ◽  
João de Andrade ◽  
Lisa Lancaster ◽  
Yolanda Mageto ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Monoclonal Antibody ◽  
Growth Factor ◽  
Idiopathic Pulmonary Fibrosis ◽  
Connective Tissue ◽  
Pulmonary Fibrosis ◽  
Pulmonary Function ◽  
Connective Tissue Growth Factor ◽  
Tissue Growth ◽  
Open Label

FG-3019 is a fully human monoclonal antibody that interferes with the action of connective tissue growth factor, a central mediator in the pathogenesis of fibrosis.This open-label phase 2 trial evaluated the safety and efficacy of two doses of FG-3019 administered by intravenous infusion every 3 weeks for 45 weeks in patients with idiopathic pulmonary fibrosis (IPF). Subjects had a diagnosis of IPF within the prior 5 years defined by either usual interstitial pneumonia (UIP) pattern on a recent high-resolution computed tomography (HRCT) scan, or a possible UIP pattern on HRCT scan and a recent surgical lung biopsy showing UIP pattern. Pulmonary function tests were performed every 12 weeks, and changes in the extent of pulmonary fibrosis were measured by quantitative HRCT scans performed at baseline and every 24 weeks.FG-3019 was safe and well-tolerated in IPF patients participating in the study. Changes in fibrosis were correlated with changes in pulmonary function.Further investigation of FG-3019 in IPF with a placebo-controlled clinical trial is warranted and is underway.

Apatinib as third-line or beyond therapy in patients with chemotherapy-refractory advanced or metastatic adenocarcinoma of stomach or gastroesophageal junction: An open-label, multicenter, post-marketing phase IV study (Ahead-G201).

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 103-103
Author(s):  
Shukui Qin ◽  
Wenying Deng ◽  
Lu Wen ◽  
Junsheng Wang ◽  
Guifang Zhang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Gastroesophageal Junction ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Primary Objective ◽  
Phase Iii ◽  
Open Label ◽  
Safety And Efficacy ◽  
Post Marketing ◽  
Phase Iv

103 Background: The clinical benefit and safety profile of apatinib in advanced gastric cancer have been established in the randomised controlled phase III clinical trial (J Clin Oncol. 34(13):1448-54). A post-marketing study to confirm the safety and efficacy of apatinib is ongoing in a broad range of patients (pts). Methods: This is a single-arm, open-label, multi-center, Phase IV trial with the target sample size of 2000+ (ClinicalTrials.gov Identifier: NCT02426034). Pts were recruited to receive oral apatinib until disease progression, death or unacceptable toxicity. The primary objective was safety, and the secondary objectives included overall response rate (ORR), disease control rate (DCR), progression free survival (PFS) and overall survival (OS). Results: Herein, we report the preliminary data as documented in the EDC System. As of Jul 10, 2017, 1037 pts were enrolled from 138 hospitals across China. Pts characteristics were: median age 59 yrs, male/female 72.0/28.0%, ECOG PS 0/1/≥2 16.6/66.2/17.2%, stage IV 91.0%. 336 (32.4%) pts interrupted treatment and dose modification occurred in 172 (16.6%) pts (reduction 132/12.7%; rise 87/8.4%). Eventually, the mean dosage was 526.2 mg/d. 652 (62.9%) pts had 4407 drug-related adverse events (DRAEs). Grade ≥3 DRAEs occurred in 300 (28.9%) pts. Severe AEs were reported by 221 (21.3%) pts. The most common DRAEs were proteinuria (19.3%), hypertension (18.8%), leukocyte decrease (16.4%), fatigue (14.2%), platelet decrease (13.6%), hand-foot-skin reaction (11.1%) and neutrophil decrease (10.1%). 820 pts were evaluable for efficacy analysis. The best ORR and DCR were 10.7% and 70.0%, respectively. The median PFS and OS were 4.60 (95%CI, 3.25–4.73) and 6.57 (95%CI, 5.78–7.59) months, respectively. Conclusions: Apatinib monotherapy is effective and has a favorable toxicity profile in real-world clinical setting. The preliminary results of this Phase IV study confirmed the safety and efficacy of apatinib demonstrated in the Phase II and III trials. Updated results will be discussed. Clinical trial information: NCT02426034.

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