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Clinical trials
catalyst calendar across sponsors →Studies where HALO is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
33 interventional · 22 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| 52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With HypogonadismNCT06689085Increase in testosterone, as evaluated using PK parametersOpen-label · Treatment | Phase 3 | Recruiting | Combination product: Testosterone enanthate | Hypogonadism, Male | 100 | Mar 2028 | ≤ 589 d | 2026-02-18 |
| Study of PEGPH20 With Cisplatin (CIS) and Gemcitabine (GEM); PEGPH20 With Atezolizumab (ATEZO), CIS, and GEM; and CIS and GEM Alone in Participants With Previously Untreated, Unresectable, Locally Advanced, or Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder AdenocarcinomaNCT03267940results2020-02-07Run-in Portion: Number of Participants With Adverse Events (AEs)Randomized · Open-label · TreatmentStudy Protocol ↗ | Phase 1 | Terminatedsponsor's stated reason: Sponsor decision | Drug: PEGPH20, CIS, GEM, Atezolizumab | Cholangiocarcinoma Non-resectable, Cholangiocarcinoma, Intrahepatic, Cholangiocarcinoma, Extrahepatic, Gallbladder Adenocarcinoma | 85 | 2019-11-11actual | — | 2020-02-07 |
| A Study of PEGylated Recombinant Human Hyaluronidase in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal AdenocarcinomaNCT02715804results2020-07-14Overall SurvivalRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Sponsor decision | Other: Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20) · Drug: Placebo, nab-Paclitaxel, Gemcitabine | Pancreatic Ductal Carcinoma | 492 | 2019-11-04actual | — | 2020-07-14 |
| A Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) With Pembrolizumab in Participants With Selected Hyaluronan High Solid TumorsNCT02563548results2020-02-07Dose-Escalation Phase: Number of Participants With Dose-Limiting Toxicity (DLT)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: PEGPH20, Pembrolizumab | NSCLC, Gastric Cancer | 56 | 2019-03-26actual | — | 2020-02-07 |
| PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Participants With Stage IV Untreated Pancreatic CancerNCT01839487results2020-07-20Progression-Free Survival (PFS)Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: PEGPH20, Nab-paclitaxel, Gemcitabine, Dexamethasone, Enoxaparin | Metastatic Pancreatic Cancer | 279 | 2018-05-01actual | — | 2020-07-20 |
| A Phase 1b Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) Combined With Docetaxel in Subjects With Recurrent Previously Treated Locally Advanced or Metastatic NSCLCNCT02346370results2019-02-08Number of Dose Limiting Toxicities (DLTs)Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: Changing standard of care therapy regimen | Drug: PEGylated recombinant human hyaluronidase PH20, Docetaxel | Non-small Cell Lung Cancer | 16 | 2016-08-09actual | — | 2019-02-08 |
| Study of Gemcitabine + PEGPH20 vs Gemcitabine Alone in Stage IV Previously Untreated Pancreatic CancerNCT01453153results2018-11-30Number of Participants With a Dose-limiting Toxicity (DLT)Randomized · Double-masked · Treatment | Phase 1/2 | Completed | Drug: Gemcitabine, PEGPH20, Placebo | Stage IV Pancreatic Cancer | 28 | Feb 2014actual | — | 2018-11-30 |
| CONSISTENT 1: Metabolic and Safety Outcomes of Hylenex Recombinant (Hyaluronidase Human Injection) Preadministered at CSII Infusion Site in Participants With Type 1 Diabetes Mellitus (T1DM)NCT01848990results2014-10-29Change From Baseline to 6 Months in Glycosylated Hemoglobin (HbA1c)Randomized · Open-label · Treatment | Phase 4 | Completed | Drug: Commercial Hylenex® recombinant (hyaluronidase human injection), Precommercial Hylenex recombinant (hyaluronidase human injection), Insulin lispro, Insulin aspart, Insulin glulisine | Type 1 Diabetes Mellitus | 456 | Feb 2014actual | — | 2018-11-07 |
| A Study of Continuous Subcutaneous Insulin Infusion (CSII) Pump Function in Subjects With Type 1 Diabetes With Recombinant Human Hyaluronidase (rHuPH20)NCT03662334results2019-02-01Part 1: Area Under the Curve (AUC) of Glucose Infusion Rate (GIR) From 0-6 HoursRandomized · Triple-masked · Treatment | Phase 4 | Completed | Drug: Rapid Acting insulin with pre-treatment of rHuPH20 · Device: Sham injection | Type 1 Diabetes Mellitus | 14 | 2014-02-27actual | — | 2019-02-01 |
| Phase 1 Safety, Tolerability and PK Study of Ondansetron and Hylenex Recombinant in Healthy VolunteersNCT01572012Evaluation of Overall SafetyRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: Ondansetron, Ondansetron + Hylenex, Zofran ODT, Ondansetron solution | Healthy | 12 | Nov 2013actual | — | 2014-01-24 |
| Study of PEGPH20 With Initial Dexamethasone Premedication Given Intravenously to Patients With Advanced Solid TumorsNCT01170897Maximally Tolerated Dose (MTD) of PEGPH20 when given to patients with cancerNon-randomized · Open-label | Phase 1 | Completed | Drug: PEGPH20 | Solid Tumor | 27 | Oct 2013actual | — | 2014-01-29 |
| Randomized, Double Blind, 2 Way Crossover Study of CSII With, Versus Without, Pretreatment With Human HyaluronidaseNCT01526733results2014-09-29Early Insulin Exposure (%AUC[0-60])Randomized · Triple-masked · Treatment | Phase 4 | Completed | Drug: Sham Injection, Recombinant human hyaluronidase PH20, Insulin aspart, Insulin lispro | Type 1 Diabetes Mellitus | 25 | Aug 2012actual | — | 2019-02-26 |
| Safety Study of PEGPH20 Given to Patients With Advanced Solid TumorsNCT00834704To determine the recommended phase 2 dose (RP2D) of PEGPH20. To evaluate the safety and tolerability of PEGPH20 in advanced cancer patients over a range of doses.Non-randomized · Open-label | Phase 1 | Completed | Drug: PEGPH20 | Solid Tumor | 14 | Jun 2012actual | — | 2013-03-26 |
| Randomized, Double-blind, Crossover, Pharmacokinetic (PK) and Glucodynamic (GD) Study of Continuous Subcutaneous Insulin Infusion (CSII) in Participants With Type 1 Diabetes Mellitus (T1DM)NCT01275131results2014-07-25Early Insulin Exposure (%AUC[0-60]), Stage 1Randomized · Triple-masked · Basic science | Phase 1 | Completed | Drug: Insulin aspart, Recombinant human hyaluronidase PH20 (rHuPH20) | Type 1 Diabetes Mellitus | 45 | Dec 2011actual | — | 2014-07-25 |
| Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes MellitusNCT01194245results2014-08-19Change From Baseline in Glycosylated Hemoglobin A1C (HbA1c) at the End of Each Treatment PeriodRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: Insulin lispro, recombinant human hyaluronidase PH20, Insulin aspart, Insulin glulisine, Insulin glargine | Diabetes Mellitus, Type 1 | 135 | Aug 2011actual | — | 2019-02-26 |
| Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Patients With Type 2 Diabetes MellitusNCT01194258results2014-08-20Change From Baseline in Glycosylated Hemoglobin A1C (HbA1C) at the End of Each Treatment PeriodRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: Insulin lispro, Insulin aspart, Recombinant human hyaluronidase PH20, Insulin glulisine, Insulin glargine | Diabetes Mellitus, Type II | 132 | Aug 2011actual | — | 2014-08-20 |
| Safety Study of Subcutaneously-Injected Prandial INSULIN-PH20 NP Compared to Insulin Lispro Injection in Participants With Type 1 Diabetes MellitusNCT00883558results2014-09-08Postprandial Glucose ExcursionRandomized · Open-label | Phase 2 | Completed | Drug: Insulin Lispro, regular human insulin, recombinant human hyaluronidase PH20, Insulin glargine | Diabetes Mellitus, Type 1 | 48 | Feb 2010actual | — | 2014-09-08 |
| A Pharmacokinetic and Glucodynamic Study of Subcutaneously Administered Insulin Analogs With rHuPH20 Compared to Insulin Analogs AloneNCT00979875results2014-07-14Area Under the Concentration-time Curve for Serum Insulin From Time 0 to 60 Minutes (AUC0-60)Randomized · Double-masked | Phase 1 | Completed | Drug: Recombinant human hyaluronidase PH20 (rHuPH20), Insulin lispro, Insulin glulisine, Insulin aspart | Healthy | 14 | Feb 2010actual | — | 2014-07-14 |
| Subcutaneous Rehydration Compared to Intravenous RehydrationNCT00773175results2018-11-07Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Randomized ParticipantsRandomized · Open-label · Treatment | Phase 4 | Completed | Drug: recombinant human hyaluronidase | Dehydration | 148 | Nov 2009actual | — | 2018-11-07 |
| Liquid Meal Study With Insulin Lispro With/Without Recombinant Human Hyaluronidase PH20 (rHuPH20) and Regular Human Insulin With rHuPH20 to Compare Pharmacokinetics, Postprandial Glycemic Response, and Optimal Insulin Dose in Participants With Type 2 Diabetes Mellitus (T2DM)NCT00916357results2014-08-18Postprandial Glucose (PPG) Excursion Following a Liquid MealRandomized · Double-masked | Phase 2 | Completed | Drug: Humalog, Humulin-R, Recombinant human hyaluronidase PH20 (rHuPH20) | Diabetes Mellitus, Type 2 | 23 | Nov 2009actual | — | 2014-08-18 |
| Pharmacokinetic, Safety and Tolerability Study of SC Administered Bisphosphonate With rHuPH20 vs Bisphosphonate AloneNCT00807963Assessment of local tolerability of injected drug productRandomized · Single-masked · Other | Phase 1 | Completed | Drug: rHuPH20, zoledronic acid | Risk Factors for or a Diagnosis of Osteoporosis | 31 | 2009-09-21actual | — | 2018-08-15 |
| Study of the Intradermal Injection of rHuPH20 or Placebo in Participants With Nickel Allergic Contact DermatitisNCT00928447results2021-12-17Number of Participants With Positive Reaction Scores Based Upon ICDRG Scoring Scale: Regimen 1Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: rHuPH20, Placebo | Dermatitis, Allergic Contact | 22 | 2009-09-13actual | — | 2021-12-17 |
| Dose-Ranging, Pharmacokinetic (PK), Glucodynamic (GD), Safety and Tolerability Study of Subcutaneously (SC) Administered Humulin R and Humalog With or Without rHuPH20NCT00803972Insulin AUCRandomized · Single-masked · Other | Phase 1 | Completed | Drug: rHuPH20, Insulin Human Injection, Insulin Lispro Injection | Healthy Volunteers | 42 | 2009-08-28actual | — | 2018-08-15 |
| Safety Study of Recombinant Human Hyaluronidase (Chemophase) in Combination With Mitomycin in Participants With Superficial Bladder CancerNCT00318643results2021-10-29Maximum Tolerated Dose (MTD) of Chemophase in Combination With MMCNon-randomized · Open-label · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: Mitomycin C, Chemophase | Bladder Cancer | 27 | 2009-08-11actual | — | 2021-10-29 |
| Pharmacokinetic and Glucodynamic Crossover Study of Subcutaneously (SC) Administered Insulin Lispro + Recombinant Human Hyaluronidase (rHuPH20) and Regular Human Insulin + rHuPH20 Compared to Insulin Lispro AloneNCT00862849results2014-07-11Intra-participant Variability in Percent of Total Area Under the Plasma Insulin Concentration-Versus-Time Curve Attained by Time T (%AUC[0-T])Double-masked | Phase 1 | Completed | Drug: Insulin Lispro, Regular Human Insulin, rHuPH20 | Diabetes Mellitus | 22 | Jun 2009actual | — | 2014-07-22 |
| Phase II Pharmacokinetics Study of Humalog and Humulin-R With and Without rHuPH20 in Type 1 Diabetes MellitusNCT00774800results2014-09-05Area Under the Insulin Concentration-time Curve for the First Hour (AUC0-60)Single-masked · Treatment | Phase 2 | Completed | Drug: Humalog, Humulin-R, Recombinant human hyaluronidase PH20 (rHuPH20) · Other: Liquid meal | Type 1 Diabetes Mellitus | 22 | Mar 2009actual | — | 2019-02-26 |
| Study of Immediate Post-Operative Intravesical Instillation of Chemophase® in Patients With Superficial Bladder CancerNCT00782587Safety and Tolerability of immediate post-operative instillation of Chemophase.Open-label · Treatment | Phase 1 | Completed | Drug: Chemophase | Superficial Bladder Cancer | 14 | Mar 2009actual | — | 2010-02-08 |
| Pharmacokinetic (PK), Pharmacodynamic (PD), and Safety Study of Subcutaneously Administered Humalog® With and Without Recombinant Human Hyaluronidase (rHuPH20)and Humulin-R® With and Without rHuPH20NCT00705536results2014-07-14Time to Maximum Serum Insulin Concentration (Tmax)Randomized · Double-masked · Health services research | Phase 1 | Completed | Drug: Humalog, Humulin-R, Recombinant human hyaluronidase PH20 (rHuPH20) | Diabetes Mellitus | 26 | Feb 2008actual | — | 2019-02-26 |
| Study of Subcutaneous Hydration Enabled by Human Recombinant Hyaluronidase (Hylenex)NCT00656370results2010-05-14The Participant's Assessment of Discomfort at the Infusion Site on a Visual Analog Scale (VAS)Randomized · Quadruple-masked · Treatment | Phase 4 | Completed | Drug: recombinant human hyaluronidase | Healthy | 15 | 2008-01-30actual | — | 2018-10-17 |
| INFUSE Morphine StudyNCT00593281• Determine the Tmax and other pharmacokinetic parameters of morphine injected subcutaneously with HYLENEX compared to without HYLENEX and injected intravenouslyRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Hylenex | Pain | 13 | Oct 2006actual | — | 2008-01-14 |
| A Phase IIIB Dose Comparison Study of Subcutaneous Hydration With and Without Human Recombinant Hyaluronidase (HYLENEX) in Volunteer SubjectsNCT00311519Average infusion flow rate (mL/hr) derived from the time to infuse 400 mL of lactated ringersRandomized · Double-masked · Treatment | Phase 4 | Completed | Drug: Hylenex | Healthy | 50 | — | — | 2006-04-06 |
| Study of a Large Protein Molecule Administered With Escalating Doses of Recombinant Human HyaluronidaseNCT00369187AUCNon-randomized · Open-label · Treatment | Phase 4 | Completed | Drug: large protein molecule | Rheumatoid Arthritis | 15 | — | — | 2008-01-10 |
| A Study of the Subcutaneous Injection of a Viscous Antibody Solution With Recombinant Human HyaluronidaseNCT00435604The time to inject 20 mL of a viscous antibody solution with and without rHuPH20.Randomized · Double-masked · Health services research | Phase 1 | Completed | Drug: Hylenex | Healthy | 15 | — | — | 2011-10-17 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19